VITROS XT 7600 Integrated System with Version 3 — Class II medical device recall Z-1676-2022
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2022-09-14, distributed nationwide. Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shi
| Recall number | Z-1676-2022 |
|---|---|
| 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 | 2022-07-19 |
| Classified | 2022-09-02 |
| Reported by FDA | 2022-09-14 |
| 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 |
| Quantity | 1,148 units |
| UPC / GTIN / UDI-DI | 10758750031610 |
Product
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Reason for recall
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
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-1676-2022. 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.