FDA Device recall Z-0214-2022
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 determinat…
- FDA Device
- Class II
- terminated
- Published 2021-11-17
On 2021-11-17 the FDA classified a Class II recall of 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 determinat… by Biocheck, citing immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0214-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-14 |
| Published | 2021-11-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biocheck |
| Distribution | CA, FL, MI, NJ, OH |
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
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Identifiers
| code_info | Lot # RN-60831 or RN-60923 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0214-2022%22
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