Open, ClassifiedPosted Apr 25, 2025·Initiated Mar 31, 2025
Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Bifurcated Outflow Patient Line (P/N 902-00040P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).
Reason: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Root cause: Process design
Recalling firm: Belmont Instrument LLCType: Warmer, Thermal, Infusion FluidDistribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.Recall #Z-1676-2025
Open, ClassifiedPosted Apr 25, 2025·Initiated Mar 31, 2025
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032.
The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The two components are packaged separately in individual pouches and placed in the same case for shipment. The female quick connector that may be cracked is located on the Heat Exchanger/Patient Line set.
Reason: Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Root cause: Process design
Recalling firm: Belmont Instrument LLCType: Warmer, Thermal, Infusion FluidDistribution: Nationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI. International distribution to Czechia, Italy, Norway.Recall #Z-1678-2025
Open, ClassifiedPosted Apr 24, 2025·Initiated Mar 27, 2025
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Reason: When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
Root cause: Software design
Recalling firm: Beckman Coulter, Inc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution.Recall #Z-1664-2025
Open, ClassifiedPosted Apr 24, 2025·Initiated Mar 20, 2025
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).
Reason: The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
Root cause: Device Design
Recalling firm: Abbott Molecular, Inc.Type: Real Time Nucleic Acid Amplification SystemDistribution: Worldwide - US Nationwide distribution.Recall #Z-1665-2025 Open, ClassifiedPosted Apr 24, 2025·Initiated Apr 16, 2025
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Reason: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
Root cause: Device Design
Recalling firm: Remote Diagnostic Technologies Ltd.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IS, IT, KY, MY, NL, NO, OM, PL, PT, RO, SA, SE, SG, SI, SL, TH, ZA.Recall #Z-1666-2025
Open, ClassifiedPosted Apr 24, 2025·Initiated Apr 4, 2025
Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number: MXU-RV71, MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors.
The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas
Component: N/A
Reason: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Root cause: Device Design
Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: US: NJ, WA, Puerto Rico
OUS: NoneRecall #Z-1669-2025
Open, ClassifiedPosted Apr 24, 2025·Initiated Apr 4, 2025
Brand Name: Rover
Product Name: Mobile X-ray System
Model/Catalog Number:MXU-RV35
Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors.
The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas
Component: N/A
Reason: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Root cause: Device Design
Recalling firm: Micro-X Ltd.Type: System, X-Ray, MobileDistribution: US: NJ, WA, Puerto Rico
OUS: NoneRecall #Z-1670-2025
Open, ClassifiedPosted Apr 24, 2025·Initiated Apr 17, 2025
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Reason: Incorrect blister labelling.
Root cause: Under Investigation by firm
Recalling firm: Straumann USA LLCType: Abutment, Implant, Dental, EndosseousDistribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.Recall #Z-1671-2025
Open, ClassifiedPosted Apr 23, 2025·Initiated Mar 12, 2025
Brand Name: Novasight Hybrid System
Product Name: Novasight Hybrid Catheter
Model/Catalog Number: TA-06-0001
Product Description: Common Name: Diagnostic intravascular catheter
Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel.
Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
Reason: Due to manufacturing issues there is a potential for the catheter sheath to detach.
Root cause: Process control
Recalling firm: Conavi Medical Inc.Type: Catheter, Ultrasound, IntravascularDistribution: US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and ChinaRecall #Z-1585-2025
Open, ClassifiedPosted Apr 23, 2025·Initiated Apr 3, 2025
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Reason: Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
Root cause: Nonconforming Material/Component
Recalling firm: Globus Medical, Inc.Type: Growing Rod System- Magnetic ActuationDistribution: US Nationwide distribution in the state of AR.Recall #Z-1657-2025
Open, ClassifiedPosted Apr 23, 2025·Initiated Oct 2, 2023
Edge Biologicals
STERILE WATER, 3ML, 100/PK CAT T-0780
Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations
Reason: Due to product outer packaging incorrectly labeled.
Root cause: Labeling mix-ups
Recalling firm: Edge Biologicals IncType: Transport Medium, Notified Per The Vtm GuidanceDistribution: U.S. Nationwide distribution in the state of PA.Recall #Z-1658-2025
Open, ClassifiedPosted Apr 23, 2025·Initiated Mar 21, 2025
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090
Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092
The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.
Reason: ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.
Root cause: Component design/selection
Recalling firm: Radiometer Medical ApSType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: U.S.: AL, AR, AZ, BM CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
O.U.S.: Canada, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Dominican Republic, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Iran, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe, Australia, New Zealand, New Caledonia, Tokelau, Austria, Belgium, Netherlands, China, Croatia, Czech Republic, Slovakia, Denmark, Iceland, Finland, Estonia, France, Germany, Hong Kong, Hungary, India, Brunei, Italy, Japan, Kazakhstan, Malaysia, Mexico, Norway, Poland, Russia, Singapore, South Africa, Cameroon, Ivory Coast, Malawi, South Korea, Spain, Portugal, Sweden, Switzerland, Turkey, United Kingdom, IrelandRecall #Z-1659-2025
Open, ClassifiedPosted Apr 23, 2025·Initiated Apr 1, 2025
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Reason: Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Root cause: Software design
Recalling firm: Philips North America LlcType: System, X-Ray, Tomography, ComputedDistribution: Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg, Mauritius, Mexico, Monaco, Morocco, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, R¿union, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, T¿rkiye, Turkmenistan, United Kingdom, UAE & Yemen.Recall #Z-1660-2025 Open, ClassifiedPosted Apr 23, 2025·Initiated Mar 27, 2025
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Reason: The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.
Root cause: Process change control
Recalling firm: IHB OPERATIONS B.V.Type: Table, Operating-Room, Ac-PoweredDistribution: US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, ID, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NM, NY, PA, TN, TX, UT, VA, WI, WV.Recall #Z-1663-2025
Open, ClassifiedPosted Apr 22, 2025·Initiated Mar 3, 2025
stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented
Reason: A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking.
" Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect)
" Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
Root cause: Under Investigation by firm
Recalling firm: Tornier, IncType: Prosthesis, Elbow, Semi-Constrained, CementedDistribution: OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, GermanyRecall #Z-1651-2025
Open, ClassifiedPosted Apr 22, 2025·Initiated Mar 18, 2025
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-01
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Root cause: Software change control
Recalling firm: Abbott LaboratoriesType: Counter, Differential CellDistribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.Recall #Z-1652-2025 Open, ClassifiedPosted Apr 22, 2025·Initiated Mar 18, 2025
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-03
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Root cause: Software change control
Recalling firm: Abbott LaboratoriesType: Counter, Differential CellDistribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.Recall #Z-1653-2025 Open, ClassifiedPosted Apr 22, 2025·Initiated Mar 18, 2025
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-10
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Root cause: Software change control
Recalling firm: Abbott LaboratoriesType: Counter, Differential CellDistribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.Recall #Z-1654-2025 Open, ClassifiedPosted Apr 22, 2025·Initiated Mar 18, 2025
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-13
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Root cause: Software change control
Recalling firm: Abbott LaboratoriesType: Counter, Differential CellDistribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.Recall #Z-1655-2025 Open, ClassifiedPosted Apr 22, 2025·Initiated Mar 18, 2025
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 04U42-84
Software Version: All software versions
Product Description: CELL-DYN Ruby
Reason: When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Root cause: Software change control
Recalling firm: Abbott LaboratoriesType: Counter, Differential CellDistribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY and OUS (foreign) to countries of: Afghanistan, Albania, Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Croatia, Czech Rebublic, Ecuador, Egypt, El Salvador, Ethiopia, France, Gambia, Gaza & Jericho, Germany, Greece, Guatemala, Guana, Haiti, Honduras, Hong King, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Lithuania, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Moldova, Montenegro, Morocco, Myanmar, New Caledonia, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, SRI Lanka, St. Lucia, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turk & Caicos, Turkey, UAE, Uganda, UK, Ukraine, Uruguay, Uzbekistan, Vietnam, and Yemen.Recall #Z-1656-2025