# FDA recall Z-0214-2022

> **BioCheck, Inc.** · Class II · device recall initiated 2021-10-14.

## 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

- **Recall number:** Z-0214-2022
- **Recalling firm:** BioCheck, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0214-2022. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0214-2022. Source: US FDA. Licensed CC0.

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