# FDA recall Z-1978-2021

> **NeuMoDx Molecular Inc** · Class II · device recall initiated 2021-05-04.

## Product

NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

## Reason for recall

There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1978-2021
- **Recalling firm:** NeuMoDx Molecular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-04
- **Report date:** 2021-07-07
- **Termination date:** 2022-06-21

- **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-1978-2021

## Citation

> AI Analytics. FDA recall Z-1978-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1978-2021. Source: US FDA. Licensed CC0.

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