FDA Device recall Z-1233-2024
VITROS XT 7600 Integrated System, Catalog No. 6844461
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of VITROS XT 7600 Integrated System, Catalog No. 6844461 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-1233-2024 |
| 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 XT 7600 Integrated System, Catalog No. 6844461
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 UDI-DI 10758750031610 Serial Numbers: US: J76000050 J76000878 J760015…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 J7600052 |
|---|
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-1233-2024%22
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