BioCheck, Inc. Recall 88869
Description: 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.
BioCheck, Inc. Recall 88869 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0214-2022 |
| Event ID | 88869 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria |
| Quantity | 314 kits |
| Recall Reason | Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. |
| Device Classification | 20211117 |
| Device Code Info | Lot # RN-60831 or RN-60923 |
| Center Classification Date | 20211110 |
| Recall Initiation Date | 20211014 |
| Recalling Firm | BioCheck, Inc. |
| Initial Notification | Letter |
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