Becton-Dickinson Clay Adams SeroFuge 2002

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Central / core laboratory
• Point-of-care testing stations
• Blood bank
• Microbiology lab

Documents & Manuals

• Becton Dickson SeroFuge 2002 ManualDocument · External
• Becton DicksonManualDocument · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

• RECALL

  BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

• RECALL

  Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.

• RECALL

  Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.

• RECALL

  The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.

• RECALL

  Microbiological identification media may exhibit reduced levels of Vancomycin.

• RECALL

  The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for culture and sensitivity, it is possible

• RECALL

  Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

• RECALL

  In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification.

• RECALL

  Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.

• RECALL

  An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.

• RECALL

  In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.

• RECALL

  Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results.

• RECALL

  BD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.

• RECALL

  Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product..

• RECALL

  BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.

• RECALL

  In vitro diagnostic test kit is defective and may cause false positive or false negative results.

• RECALL

  In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.

• RECALL

  In vitro diagnostic device components are mislabeled.

• RECALL

  In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.

• RECALL

  In vitro diagnostic reagent to aid in the diagnosis of Salmonellosis may exhibit decreased or no reactivity. If proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. If control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.

• RECALL

  The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.

• RECALL

  Diagnostic test reagents may not meet quality control specifications.

• RECALL

  The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.

• RECALL

  Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

• RECALL

  A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the towelettes.

• RECALL

  An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.

• RECALL

  Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning.

• RECALL

  Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.

• RECALL

  In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.

• RECALL

  In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.

• RECALL

  No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow.

• RECALL

  Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA).

• RECALL

  False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component.

• RECALL

  A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.

• RECALL

  An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.

• RECALL

  39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.

• RECALL

  Test Strips may not be meeting specifications at the lower range of glucose values.

• RECALL

  Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

Related calculators

From BioLab, for work done with this kind of equipment.

• RCF to RPM CentrifugeConvert between rpm and × g for any rotor
• Centrifuge k-Factor and Pelleting Timek-factor, pelleting time, and run time between rotors
• Hemocytometer Cell CountingCells per mL from a hemocytometer count
• Cell DilutionDilute a cell suspension to a target density