FDA recall Z-0214-2022

BioCheck, Inc. · Class II · device

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 for recall

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

Key facts

Status
Terminated
Initiation date
2021-10-14
Report date
2021-11-17
Termination date
2025-02-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
South San Francisco, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0214-2022