Recall Z-1233-2024
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 7600 Integrated System, Catalog No. 6844461
Codes / lots: VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031610 Serial Numbers: US: J76000050 J76000878 J76001555 J76000108 J76000905 J76001558 J76000144 J76000909 J76001559 J76000148 J76000922 J76001565 J76000179 J76000930 J76001570 J76000192 J76000968 J76001577 J76000195 J76001106 J76001581 J76000199 J76001171 J76001583 J76000200 J76001172 J76001589 J76000206 J76001206 J76001592 J76000207 J76001207 J76001595 J76000208 J76001218 J76001596 J76000241 J76001230 J76001597 J76000298 J76001231 J76001599 J76000313 J76001232 J76001600 J76000317 J76001234 J76001611 J76000324 J76001235 J76001616 J76000333 J76001239 J76001617 J76000342 J76001260 J76001620 J76000352 J76001263 J76001638 J76000353 J76001270 J76001639 J76000420 J76001274 J76001643 J76000422 J76001292 J76001644 J76000456 J76001293 J76001647 J76000459 J76001294 J76001648 J76000460 J76001331 J76001650 J76000468 J76001340 J76001652 J76000495 J76001351 J76001659 J76000502 J76001357 J76001660 J76000524 J76001370 J76001666 J76000525 J76001376 J76001667 J76000537 J76001383 J76001668 J76000561 J76001384 J76001669 J76000609 J76001385 J76001671 J76000709 J76001392 J76001674 J76000743 J76001404 J76001675 J76000747 J76001406 J76001678…
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-1233-2024
- Initiated
- January 26, 2024
- Posted by FDA
- March 1, 2024
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 142 US; 78 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-1231-2024 Class II | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 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 |