FDA Device recall Z-0061-2019
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
- FDA Device
- Class II
- ongoing
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997 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-0061-2019 |
| 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 - TSH Reagent Pack (10758750000227) 1912997
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 | 5535 5540 5550 5560 5570 5580 5590 5600 5610 5615 5620 5630 5640 5650 5655 5660 5665 5670 5675 5678 5680 5685 5690 |
|---|
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-0061-2019%22
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