T4 EIA Kit — Class II medical device recall Z-0214-2022
Terminated recall by BioCheck, Inc., reported 2021-11-17, distributed in CA, FL, MI, NJ, OH. Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
| Recall number | Z-0214-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioCheck, Inc., South San Francisco, CA, United States |
| Recall initiated | 2021-10-14 |
| Classified | 2021-11-10 |
| Reported by FDA | 2021-11-17 |
| Terminated | 2025-02-14 |
| Distributed | CA, FL, MI, NJ, OH |
| Countries outside the US | ES, NG, TW |
| Quantity | 314 kits |
| Lot numbers | RN-60831, RN-60923 |
| Model numbers | BC-1007 |
Product
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Reason for recall
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
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-0214-2022. 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.