Recall Z-0651-2019
Ortho-Clinical Diagnostics · initiated October 19, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Codes / lots: Product code: 6801375 UDI: 10758750001132 Serial Numbers: J34000132- J34002322
Reason for recall
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
FDA-determined cause: Software Manufacturing/Software Deployment
Action taken
On October 19, 2018, Ortho Clinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" notices via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers to inform them of the issue and actions to take to prevent occurrence of the anomaly. On November 19, 2018 Ortho Clinical Diagnostics re-issued correction notices to customers pertaining to the 5,1 FS system (CL2018-194_5,1FS). Customers may continue using their VITROS Systems and have been informed that the software issue will be mitigated with the next version of software. The expected dates of these software versions are included in the communication. Foreign affiliates were informed by email approximately on 21 October 2018 of the issue and instructed to notify their consignees of the issue and required actions to prevent the occurrence of the anomaly. Please refer to the Customer letter (Ref. CL2018-194_51FS, CL2018-194_3600, CL2018-194_4600, and CL2018-194_5600) for specific details on Required Actions by User. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Details
- Recall number
- Z-0651-2019
- Initiated
- October 19, 2018
- Terminated
- January 24, 2022
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 1105
- Distribution
- US Nationwide Distribution
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0650-2019 Class II | VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro…Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | 10/19/2018Terminated |
| Z-0652-2019 Class II | VITROS 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro…Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | 10/19/2018Terminated |
| Z-0653-2019 Class II | VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative…Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | 10/19/2018Terminated |