Recall Z-1227-2024
Ortho-Clinical Diagnostics, Inc. · initiated January 26, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Codes / lots: VITROS System Software Version 3.8.1 UDI-DI 10758750031986 Serial Numbers US: J34500180 J34500289 J34500422 J34500473 J34500622 J34500861 J34500887 OUS: J34500515 J34500609 J34500802 J34500940
Reason for recall
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
FDA-determined cause: Software Design Change
Action taken
On January 26, 2024, the firm sent a customer letter to all customers who have V3.8.1 installed on their VITROS Analyzer. Customers were informed of this issue and instructed to follow the instructions when using the VITROS System onboard QC package to update the QC baseline. The software will be updated to mitigate both issues within the VITROS Software QC feature. The estimated availability is 2Q2024. If you have further questions, please contact Global Services Organization at 1-800-421-3311.
Details
- Recall number
- Z-1227-2024
- Initiated
- January 26, 2024
- Posted by FDA
- March 1, 2024
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 7 US; 4 OUS
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1224-2024 Class II | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914…A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |
| Z-1225-2024 Class II | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |
| Z-1226-2024 Class II | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |
| Z-1228-2024 Class II | VITROS XT 7600 Integrated System, Catalog No. 6844461A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |