VITROS¿ 3600 Immunoassay System-Software V3 — Class II medical device recall Z-1289-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2019-05-15, distributed nationwide. Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
| Recall number | Z-1289-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2019-02-20 |
| Classified | 2019-05-06 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2021-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| Quantity | 267 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10758750002979 |
| Serial numbers | 36001160 |
Product
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Reason for recall
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
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-1289-2019. 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.