FDA Device recall Z-0503-2022
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
- FDA Device
- Class II
- ongoing
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class II recall of VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack by Ortho Clinical Diagnostics, citing lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0503-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-22 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Reason
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
Identifiers
| code_info | Lot # 2190; Product code(unique Device Identifier): 8430373 (10758750004898) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0503-2022%22
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