# FDA recall Z-0310-2022

> **DRG International, Inc.** · Class II · device recall initiated 2021-10-18.

## Product

Total Thyroxine (T4) ELISA; REF EIA-1781

## Reason for recall

Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.

## Distribution

Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM

## Key facts

- **Recall number:** Z-0310-2022
- **Recalling firm:** DRG International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-18
- **Report date:** 2021-12-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Springfield, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0310-2022

## Citation

> AI Analytics. FDA recall Z-0310-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0310-2022. Source: US FDA. Licensed CC0.

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