VITROS Immunodiagnostic Products Troponin I ES Reagent Pack — Class II medical device recall Z-2357-2023
Ongoing recall by ORTHO-CLINICAL DIAGNOSTICS, reported 2023-08-16, distributed nationwide. Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false
| Recall number | Z-2357-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS, Bridgend, N/A, United Kingdom |
| Recall initiated | 2023-06-05 |
| Classified | 2023-08-08 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 4,013 units |
| UPC / GTIN / UDI-DI | 10758750002504 |
| Lot numbers | 4800 |
| Expiration dates | 2023-06-10 |
Product
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Reason for recall
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
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-2357-2023. 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.