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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Affected units
- 314
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
Related recalls
Same hazard · quality control failure
See all →- SevereBD Phoenix Panel NMIC-306 Recalled for Quality Control Failures
FDA (Devices) · 2026-10-21
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighPreeclampsia growth factor assay recalled over out-of-range quality control values
FDA (Devices) · 2026-04-15
Similar recalls
- ModerateTotal Thyroxine ELISA Test Kits Recalled for Failed Quality Controls
FDA (Devices) · 2021-12-08
- ModerateOrtho-Clinical VITROS TT4 Calibrator Recalled for Calibration Failures
FDA (Devices) · 2014-05-28
- ModerateTosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
FDA (Devices) · 2026-07-22
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Total T4 Reagent Packs
FDA (Devices) · 2016-08-10
- ModerateT4 Total ELISA kit box expiry exceeds the standards' shelf life
FDA (Devices) · 2025-08-13
- ModerateDiagnostic Hybrids Recalls MicroVue Bb Plus EIA Kits Due to Inaccurate Results
FDA (Devices) · 2015-09-09