Device 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.
Z-0214-2022
Product summary
- Firm
- BioCheck, Inc.
- Event
- Event 88869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 314 kits
- Official record key
device-enforcement:Z-0214-2022
Official wording
Reason: Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Code information: Lot # RN-60831 or RN-60923
Distribution pattern: US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
Derived failure modes
-
Unknown
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.