Ortho Clinical Diagnostics ORTHO Workstation
Ortho Clinical Diagnostics · Model ORTHO Workstation
Increase accuracy - provide the accuracy your patients deserve with a validated system of ID-MTS™ Gel Cards - the serological standard for blood banks - with centrifuge and incubator Maximize space - maximize space in your lab with this compact 2-in-1 system that integrates the ID-MTS™ Gel Cards, centrifuge, and an incubator Simplify operations - language-neutral icons, enhanced alarm systems, easy-to-perform centrifuge QC using a tachometer, and quick access to holding area for centrifuge balance-card Improve process controls - more control over processing with incubator temperature monitoring with a visual indicator, a unique beeping pattern to indicate cycle completion, enhanced error code intelligence for troubleshooting, and a quiet centrifuge with translucent panels for visual monitoring Reduce your lab's footprint - a system designed with the environment in mind.
Key tips
- ·Run QC controls before trusting any repair - an analyzer that passes self-test can still report clinically wrong results.
- ·Rule out a reagent lot change before opening the instrument - it can look exactly like a hardware fault.
- ·Centrifuge rotors have a hard retirement age/cycle limit regardless of visible condition - don't eyeball it.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
QC / calibration failure / poor peaks or results
HighSymptoms: Controls out of range, calibration fails, poor chromatographic peaks, baseline drift.
Root cause: Column / mobile-phase issue, detector lamp ageing, a pump / seal fault, or a reagent problem.
Pump pressure / flow instability
MediumSymptoms: Pressure spikes or drops, unstable flow, retention-time drift.
Root cause: Worn piston seals or check valves, a blocked frit, or air in the pump head.
Autosampler / injector fault
MediumSymptoms: Missed injections, poor injection precision, vial-detection errors.
Root cause: Rotor-seal wear, a syringe / metering fault, or needle mis-alignment.
Detector / flow-cell fault
MediumSymptoms: High noise, low signal, detector-error message.
Root cause: Lamp at end of life or a contaminated flow cell.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Pump piston seals / check valves
Class Frequent wear itemRel. cost $$R&R Moderate
Detector lamp
Class Frequent wear itemRel. cost $$R&R Moderate
Injector rotor seal
Class Frequent wear itemRel. cost $$R&R Moderate
Flow cell
Class Periodic replacementRel. cost $$$R&R Moderate
Inlet frits / filters
Class Frequent wear itemRel. cost $R&R Fairly easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Pump piston seals / check valves | Frequent wear item | $$ | Moderate |
| Detector lamp | Frequent wear item | $$ | Moderate |
| Injector rotor seal | Frequent wear item | $$ | Moderate |
| Flow cell | Periodic replacement | $$$ | Moderate |
| Inlet frits / filters | Frequent wear item | $ | Fairly easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily QC controls run and reviewed
- ·Calibration verification per assay
- ·Routine cleaning and decontamination
- ·Scheduled reagent-path and pump-tubing maintenance
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: QC / calibration failure or poor peaks
- Confirm the correct column, mobile phase, temperature and reagents.
- Check the detector lamp energy and replace it if low.
- Clean or replace the flow cell.
- Purge the system and let it equilibrate.
- Run a known standard to confirm performance.
Symptom: Pump pressure / flow instability
- Check the mobile-phase level, degassing and the inlet frit.
- Prime the pump and purge air from the head.
- Inspect the piston seals and check valves for wear.
- Leak-test the fittings from pump to column.
- Replace the seals / check valves as isolated.
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
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.
- RECALL
Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
- RECALL
Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
- RECALL
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
- RECALL
VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).
- RECALL
Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using VITROS Chemistry Products Specialty Diluent (Lot F3168) or VITROS Chemistry Products FS Diluent Pack 3 (Lot 01-3266). The VITROS Instructions for Use states that if the if a C-reactive protein concentration exceeds the systems measuring (reportable or dynamic) range, dilute the sample with VITROS Specialty Diluent or a patient sample containing a low concentration of CRP. An initial threefold dilution is recommended. Internal testing determined that results using VITROS CRP Slides have the potential for approximately 51% bias using a 3x dilution factor.
- RECALL
Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type.
- RECALL
Ortho Clinical Diagnostics is recalling Lot 1630 of VITROS Calibrator Kit 16 because it will not likely meet its specified 12 months of stability.
- RECALL
Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and VITROS Chemistry Products mALB Reagent.
- RECALL
Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results obtained while using VITROS Chemistry Products NBIL DT Slides, GEN 72. OCD performed an internal investigation and confirmed that negatively biased NBIL results could occur for quality control, proficiency and patient samples. As a result, VITROS Chemistry Products DT Calibrator Kit Lots 37 &
- RECALL
Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanied by an Invalid Dilution (ID) code. The diluted results were inconsistent with results from the neat (undiluted) sample, which was within the measuring range of 2.39 - 15,000 mIU/mL. OCD's investigation determined it is possible to obtain negatively biased results if samples are diluted and tested on the VITROS ECi/ECiQ System using VITROS Total B-hCG II Reagent Packs, Lots 0484 and above.
- RECALL
Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue.
- RECALL
A software anomaly that can occur with analyzers connected to the Bypass modules listed below on an enGen" Laboratory Automation System using TCAutomation" Software Version 3.1.1 and below. When this anomaly occurs, it is possible for a sample other than the intended sample to be aspirated, potentially leading to test results being assigned to the wrong patient without error notification.
- RECALL
Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.
- RECALL
Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.
- RECALL
The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for more than 2 days.
- RECALL
Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.
- RECALL
Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.
- RECALL
Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.
- RECALL
Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
- RECALL
Falsely elevated Carbamazepine results.
- RECALL
Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
- RECALL
Potential for positively biased results in QC and patient samples.
- RECALL
Random occurrence of false positive test results.
- RECALL
Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
- RECALL
Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
- RECALL
Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.
- RECALL
Slides may exhibit random, elevated imprecision of results.
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