Recalls / —
—#174828
Product
VITROS 4600 Chemistry System, clinical chemistry analyzer
- FDA product code
- JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K063144
- Affected lot / code info
- product code: 6900440 UDI: 10758750033201 Affected software : Version 3.3.2 or above
Why it was recalled
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Root cause (FDA determination)
Software design
Action the firm took
Customers were notified prior to July 10, 2019. For the VITROS 250, 250AT, and 350 chemistry system: Do not use VITROS Calibrator Kit 32 to calibrate assays until an Ortho trained service personnel reconfigures your system(s) with the correct parameters for VITROS Calibrator Kit 32. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification by each system that may use VITROS Calibrator Kit 32 until your system is reconfigured by an Ortho trained representative. Please forward this notification if the product was distributed outside of your facility. For the VITROS 4600,5600 and 5,1 FS chemistry System: If your system is configured with User Modified parameters, choose an option provided in the Interim Resolutions section listed above. Install ADD DRV 6040 or above upon availability. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification either by each system that processes VITROS Calibrator Kit 32 or with your user documentation until DRV 6040 or above is installed on your system(s). Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Recalling firm
- Firm
- Ortho Clinical Diagnostics
- Address
- 100 Indigo Creek Dr, Rochester, New York 14626-5101
Distribution
- Distribution pattern
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Timeline
- Recall initiated
- 2019-07-08
- Terminated
- 2023-10-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #174828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.