FDA Device recall Z-0058-2019
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
- FDA Device
- Class II
- ongoing
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 by Ortho Clinical Diagnostics, citing the recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicate….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0058-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-07-12 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
Reason
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
Identifiers
| code_info | 2470 2480 2490 2501 2510 2521 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0058-2019%22
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