FDA Device recall Z-1231-2024
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) by Ortho Clinical Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1231-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-26 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Reason
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.
Identifiers
| code_info | VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial N…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 J560033 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1231-2024%22
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