Recall Z-1231-2024
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 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Codes / lots: VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers: US: J56000116 J56003369 J56000317 J56003373 J56001292 J56003377 J56001523 J56003433 J56001629 J56003477 J56001885 J56003478 J56001886 J56003484 J56001910 J56003496 J56002041 J56003541 J56002159 J56003570 J56002198 J56003578 J56002199 J56003581 J56002201 J56003583 J56002249 J56003632 J56002301 J56003646 J56002308 J56003655 J56002461 J56003668 J56002463 J56003669 J56002466 J56003670 J56002474 J56003672 J56002477 J56003725 J56002500 J56003730 J56002591 J56003752 J56002603 J56003759 J56002607 J56003774 J56002608 J56003911 J56002615 J56004068 J56002698 J56004137 J56002703 J56004174 J56002704 J56004240 J56002722 J56004325 J56002769 J56004326 J56002895 J56004485 J56003035 J56004491 J56003045 J56004498 J56003076 J56004506 J56003113 J56004512 J56003199 J56004549 J56003220 J56004551 J56003287 J56004571 J56003299 J56004577 J56003317 J56004587 J56003330 J56004589 J56003334 J56004604 J56003342 J56004606 J56003356 OUS: J56000190 J56001929 J56000246 J56001944 J56000418 J56001979 J56000425 J56002028 J56000468 J56002064 J56000512 J56002085 J56000533 J56002099 J56000665…
Reason for recall
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
FDA-determined cause: Software Design Change
Action taken
On January 26, 2024, the firm issued a customer letter to all customers who have V3.8.0 or V3.8.1 installed on their VITROS Analyzer. Customers were informed of the issue and instructed to follow the instructions when using the VITROS System onboard QC package to use the configurable Westgard Rules. The software will be updated to mitigate this issue 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-1231-2024
- Initiated
- January 26, 2024
- Posted by FDA
- March 1, 2024
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 91 US; 94 OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1229-2024 Class II | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914…A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |
| Z-1230-2024 Class II | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |
| Z-1232-2024 Class II | VITROS XT 3400 Chemistry System, Catalog No. 6844458A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |
| Z-1233-2024 Class II | VITROS XT 7600 Integrated System, Catalog No. 6844461A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |