Recall Z-1225-2024
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 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Codes / lots: VITROS System Software Version 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers US: J46000240 J46000898 J46001030 J46001293 OUS: J46000150 J46001041 J46000190 J46001042 J46000499 J46001186 J46000564 J46001187 J46000801 J46001210 J46000821 J46001217 J46000910 J46001289 J46000933 J46001639 J46001029 J46001645
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-1225-2024
- Initiated
- January 26, 2024
- Posted by FDA
- March 1, 2024
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 4 US; 18 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-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-1227-2024 Class II | VITROS XT 3400 Chemistry System, Catalog No. 6844458A 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 |