FDA Device recall Z-2066-2012
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes o…
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes o… by Ortho Clinical Diagnostics, citing software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verifi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2066-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-21 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Reason
software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
Identifiers
| code_info | Version 2.6.1 & Below |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2066-2012%22
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