# FDA recall Z-2171-2026

> **Aniara Diagnostica LLC** · Class II · device recall initiated 2026-04-01.

## Product

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

## Reason for recall

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

## Distribution

US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI

## Key facts

- **Recall number:** Z-2171-2026
- **Recalling firm:** Aniara Diagnostica LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-01
- **Report date:** 2026-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2171-2026

## Citation

> MORVS. FDA recall Z-2171-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-2171-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*