FDA Device recall Z-0848-2019
VITROS Chemistry Products VALP Reagent Pack
- FDA Device
- Class II
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class II recall of VITROS Chemistry Products VALP Reagent Pack by Ortho Clinical Diagnostics, citing negative bias results when using VITROS VALP Reagent, GEN 25.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0848-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-11 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.
Reason
Negative bias results when using VITROS VALP Reagent, GEN 25.
Identifiers
| code_info | Affected Lots/Expiry: 25-5263 2017-09-09; 25-5503 2018-01-06; 25-5727 2018-04-30; 25-5974 2018-08-14; 25-6067 2018…Affected Lots/Expiry: 25-5263 2017-09-09; 25-5503 2018-01-06; 25-5727 2018-04-30; 25-5974 2018-08-14; 25-6067 2018-11-05; 25-6393 2019-04-05 (only non expired lot) Unique Identifier:10758750006748 |
|---|
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-0848-2019%22
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