BioCheck, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0214-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 14, 2021

Date Posted: November 17, 2021

Recall Number: Z-0214-2022

Event ID: 88869

Reason for Recall:

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

Status: Terminated

Product Quantity: 314 kits

Code Information:

Lot # RN-60831 or RN-60923

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated