FDA Device recall Z-1227-2024
VITROS XT 3400 Chemistry System, Catalog No. 6844458
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of VITROS XT 3400 Chemistry System, Catalog No. 6844458 by Ortho Clinical Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1227-2024 |
| 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 3400 Chemistry System, Catalog No. 6844458
Reason
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.
Identifiers
| code_info | VITROS System Software Version 3.8.1 UDI-DI 10758750031986 Serial Numbers US: J34500180 J34500289 J34500422 J3450047…VITROS System Software Version 3.8.1 UDI-DI 10758750031986 Serial Numbers US: J34500180 J34500289 J34500422 J34500473 J34500622 J34500861 J34500887 OUS: J34500515 J34500609 J34500802 J34500940 |
|---|
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-1227-2024%22
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