# FDA recall Z-0738-2022

> **NeuMoDx Molecular Inc** · Class II · device recall initiated 2022-01-21.

## Product

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947).  Distributed in boxes of 6 assay strips in individual pouches.   Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

## Reason for recall

A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

## Distribution

US Nationwide distribution in the states of FL, MD, MI, NY.

## Key facts

- **Recall number:** Z-0738-2022
- **Recalling firm:** NeuMoDx Molecular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-21
- **Report date:** 2022-03-16

- **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-0738-2022

## Citation

> AI Analytics. FDA recall Z-0738-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0738-2022. Source: US FDA. Licensed CC0.

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