Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System… — Class II medical device recall Z-1006-2025
Ongoing recall by Ortho-Clinical Diagnostics, INc., reported 2025-01-29, distributed nationwide. The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reag
| Recall number | Z-1006-2025 |
|---|---|
| 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 | 2024-12-19 |
| Classified | 2025-01-21 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10758750012343, 10758750035809 |
| Serial numbers | 76000001-76002199 |
| Model numbers | 6272222, 6844461 |
Product
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component
Reason for recall
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
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-1006-2025. 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.