VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
This recall has been terminated (originally issued July 8, 2019).
- Company
- Ortho-Clinical Diagnostics
- Recall Initiated
- July 8, 2019
- Terminated
- October 19, 2023
- Recall Number
- Z-2184-2019
- Quantity
- 55
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Distribution
Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Lot / Code Info
product code:6801890 UDI: 10758750001644 Affected software : Version 3.1 or above
Root Cause
Software design
Action Taken
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.