VITROS 5600 Integrated System — Class II medical device recall Z-1221-2024
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2024-03-13, distributed nationwide. Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Im
| Recall number | Z-1221-2024 |
|---|---|
| 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 | 2024-01-22 |
| Classified | 2024-03-01 |
| Reported by FDA | 2024-03-13 |
| 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 |
| UPC / GTIN / UDI-DI | 10758750002740, 10758750007110 |
| Serial numbers | J36001164, J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561 and 4 more |
Product
VITROS 5600 Integrated System (New and Refurbished)
Reason for recall
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Machine access
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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.