T4 EIA Diagnostic Kit Recall Due to Shelf-Life Quality Standards Failure
BioCheck, Inc. is recalling 314 T4 EIA Kit units due to failed shelf-life standards that resulted in failed quality control tests. The kits were distributed to five U.S. states and three overseas countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is potential diagnostic inaccuracy due to shelf-life failure and failed quality controls, but no actual patient harm has been reported, making this a precautionary product reliability recall.
Plain-English summary
BioCheck, Inc. is recalling 314 T4 EIA Kit (Catalog No. BC-1007) units used for thyroid testing. The kits do not meet product shelf-life standards, resulting in failed quality control tests.
The T4 EIA Kit is an in vitro diagnostic test used to measure total thyroxine (T4) concentration in human serum for the diagnosis and treatment of thyroid disorders. When shelf-life standards are not met, the test controls fail, which means test results may be unreliable and could lead to incorrect diagnosis or treatment decisions.
The affected kits were distributed in the United States to Michigan, Florida, New Jersey, Ohio, and California. International distribution occurred to Spain, Taiwan, and Nigeria. The affected lot numbers are RN-60831 and RN-60923.
Healthcare facilities and laboratories with these kits should contact BioCheck, Inc. for instructions on returning the product or receiving replacements.
The recalled product
- 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.
- Manufacturer
- BioCheck, Inc.
- Hazard
- quality-control-failure
- inaccurate-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # RN-60831 or RN-60923
Distribution
Distributed in 5 states:
- CA
- FL
- MI
- NJ
- OH
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