# FDA recall Z-1251-2022

> **NeuMoDx Molecular Inc** · Class II · device recall initiated 2022-05-13.

## Product

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900

## Reason for recall

There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.

## Distribution

Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.

## Key facts

- **Recall number:** Z-1251-2022
- **Recalling firm:** NeuMoDx Molecular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-13
- **Report date:** 2022-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2022

## Citation

> AI Analytics. FDA recall Z-1251-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1251-2022. Source: US FDA. Licensed CC0.

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