# FDA recall Z-2093-2023

> **NeuMoDx Molecular Inc** · Class III · device recall initiated 2023-05-15.

## Product

NeuMoDx SARS-CoV-2 Assay  -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP).  REF Number: 300800

## Reason for recall

Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text  as lot number 123910 from the barcode label.

## Distribution

US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.

## Key facts

- **Recall number:** Z-2093-2023
- **Recalling firm:** NeuMoDx Molecular Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-15
- **Report date:** 2023-07-12

- **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-2093-2023

## Citation

> AI Analytics. FDA recall Z-2093-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2093-2023. Source: US FDA. Licensed CC0.

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