# FDA recall Z-1244-2022

> **Helena Laboratories, Corp.** · Class II · device recall initiated 2022-04-06.

## Product

V8 Immunodisplacement Kit REF 1803

## Reason for recall

Due to microbial growth causing interference with interpretation.

## Distribution

U.S.: FL, MO, OH, and TX    O.U.S.: Canada, Uruguay, and Vietnam,

## Key facts

- **Recall number:** Z-1244-2022
- **Recalling firm:** Helena Laboratories, Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-06
- **Report date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beaumont, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1244-2022

## Citation

> AI Analytics. FDA recall Z-1244-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1244-2022. Source: US FDA. Licensed CC0.

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