FDA Device recall Z-1287-2019
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and…
- FDA Device
- Class II
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class II recall of VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and… by Ortho Clinical Diagnostics, citing luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1287-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-20 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 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
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Identifiers
| code_info | Serial Numbers: 56003270 & above UDI: 10758750002740 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1287-2019%22
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