Recall Z-0214-2022— BioCheck, Inc.
Class II · Terminated
Class II FDA medical device recall by BioCheck, Inc., initiated 2021-10-14, terminated 2025-02-14. It names one FDA 510(k) clearance: K991432. Product: 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..
- Recalling firm
- BioCheck, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-10-14
- Terminated
- 2025-02-14
- Firm location
- South San Francisco, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.