Z-0214-2022 Class II Terminated
FDA device recall Z-0214-2022 was initiated by BioCheck, Inc. on October 14, 2021 and is designated Class II. Reason for recall: Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. The recall status is terminated (terminated February 14, 2025). Affected quantity: 314 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 17, 2021
- Initiation Date
- October 14, 2021
- Termination Date
- February 14, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 314 kits
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.
Distribution Pattern
US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
Code Information
Lot # RN-60831 or RN-60923