FDA Device recall Z-0651-2019
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical i…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical i… by Ortho Clinical Diagnostics, citing software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0651-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-19 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Reason
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Identifiers
| code_info | Product code: 6801375 UDI: 10758750001132 Serial Numbers: J34000132- J34002322 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0651-2019%22
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