South San Francisco, CA, United States
BioCheck, Inc. recalls
1 recall recorded since 2018, most recently on 14 October 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 October 2021
- Terminated
- 14 February 2025
- Reason
- Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
- Distribution
- US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria
- Initiated
- Voluntary: Firm initiated
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.