Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 the diagnosis and treatment of thyroid disorders.

U.S. FDA — Device Enforcement · United States · 2021-10-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0214-2022
Date of alert: 2021-10-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: BioCheck, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall 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 the diagnosis and treatment of thyroid disorders.

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