VITROS 5600 Integrated System — Class II medical device recall Z-2483-2020
Terminated recall by Ortho Clinical Diagnostics, reported 2020-07-08, distributed nationwide. Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in
| Recall number | Z-2483-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2020-05-20 |
| Classified | 2020-07-01 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2022-11-16 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10758750007110 |
| Serial numbers | 56000255, 56000261, 56000308, 56000315, 56000317, 56000339, 56000458, 56000513, 56000559, 56000718, 56000727, 56000741, 56000747, 56000755, 56000756, 56000786, 56000818, 56000824, 56000825, 56000843, 56000883, 56001021, 56001062, 56001089, 56001131 and 20 more |
Product
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Reason for recall
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
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-2483-2020. 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.