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.
Reported: November 17, 2021 Initiated: October 14, 2021 #Z-0214-2022
Product 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.
Reason for Recall
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Details
- Recalling Firm
- BioCheck, Inc.
- Units Affected
- 314 kits
- Distribution
- US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
- Location
- South San Francisco, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BioCheck, Inc.. Units affected: 314 kits.
Why was this product recalled? ▼
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 17, 2021. Severity: Moderate. Recall number: Z-0214-2022.
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