Recalls / —
—#167125
Product
VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
- FDA product code
- JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K081543
- Affected lot / code info
- Serial Numbers : J56000024 through J56003300
Why it was recalled
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Root cause (FDA determination)
Software design
Action the firm took
ORTHO PLUSSM is e-Communications, a service that provides subscribing customers with Ortho Clinical Diagnostics (Ortho) product notifications electronically on 15 August 2018, a customer letter (Ref. CL2018-174) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS 5600 Integrated Systems to inform them of the potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. Ortho also provided specific actions for customers to take when they observe unexpected MicroSlide assay results for a sample associated with TE1-504 and/or TE1-594 condition codes. Customers were also instructed to discuss any concerns related to this issue and previously reported results with the Laboratory Medical Director.
Recalling firm
- Firm
- Ortho-Clinical Diagnostics
- Address
- 100 Indigo Creek Dr, Rochester, New York 14626-5101
Distribution
- Distribution pattern
- Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
Timeline
- Recall initiated
- 2018-08-15
- Terminated
- 2022-01-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #167125. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.