FDA Enforcement
Class II
Terminated
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.
Recall: Z-0214-2022
·
Reported November 17, 2021
Enforcement
- Recall Number
- Z-0214-2022
- Event ID
- 88869
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- BioCheck, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 17, 2021
- Initiation Date
- October 14, 2021
- Classification Date
- November 10, 2021
- Termination Date
- February 14, 2025
- Address
- 425 Eccles Ave, N/A, South San Francisco, CA, 94080-1902, United States
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
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
Code Info
Lot # RN-60831 or RN-60923
Distribution
US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
Quantity
314 kits