VITROS Immunodiagnostic Products TT4 Reagent Pack — Class III medical device recall Z-1834-2020
Terminated recall by Ortho Clinical Diagnostics, reported 2020-05-06, distributed nationwide. The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
| Recall number | Z-1834-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2020-03-10 |
| Classified | 2020-04-30 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2022-09-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| Quantity | 3,181 |
| UPC / GTIN / UDI-DI | 10758750005147 |
| Lot numbers | 2340 |
Product
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Reason for recall
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
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-1834-2020. 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.