FDAFDA · Food and drugs·Recall number Z-0214-2022
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.
Published November 17, 2021 · Recall initiated: October 14, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioCheck, Inc.
- Distributor
- US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
- Lot
- Lot # RN-60831 or RN-60923
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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