FDA Device recall Z-0060-2019
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
- FDA Device
- Class II
- ongoing
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793 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-0060-2019 |
| 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 - Prolactin Reagent Pack (10758750000111) 1849793
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 | 2330 2340 2350 2360 2370 2380 |
|---|
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-0060-2019%22
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