VITROS XT 3400 Chemistry System — Class II medical device recall Z-1227-2024
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2024-03-13, distributed nationwide. A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistic
| Recall number | Z-1227-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2024-01-26 |
| Classified | 2024-03-01 |
| Reported by FDA | 2024-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CN, CO, ES, FR, GB, IN, IT, MX, RU, SG |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10758750031986 |
| Serial numbers | J34500180, J34500289, J34500422, J34500473, J34500515, J34500609, J34500622, J34500802, J34500861, J34500887, J34500940 |
| Model numbers | 6844458 |
Product
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1227-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.