VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack — Class II medical device recall Z-0503-2022
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2022-01-26, distributed nationwide. Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ I
| Recall number | Z-0503-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2021-11-22 |
| Classified | 2022-01-18 |
| Reported by FDA | 2022-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| Quantity | 1,416 units |
| UPC / GTIN / UDI-DI | 10758750004898 |
| Lot numbers | 2190 |
Product
VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0503-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.