BioCheck, Inc. recalls 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 qua…

Recall date

October 14, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0214-2022

FDA classification

Class II

Brand / firm

BioCheck, Inc.

Sold / distributed

US Distribution to states of: MI, FL, NJ, OH, CA; and OUS (foreign) distribution to countries of: Spain, Taiwan and Nigeria

Why it was recalled

Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.