VITROS 5600 Integrated System-For use in the in vitro quantitative — Class II medical device recall Z-0079-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2018-10-17, distributed nationwide. Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide wi
| Recall number | Z-0079-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2018-08-15 |
| Classified | 2018-10-05 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2022-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CL, ES, FR, GB |
| Serial numbers | J56000024 |
| Model numbers | 6802413 |
Product
VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
Reason for recall
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
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-0079-2019. 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.