# FDA recall Z-2255-2023

> **NeuMoDx Molecular Inc** · Class II · device recall initiated 2023-05-24.

## Product

NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s)  Ref: 100100

## Reason for recall

Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results

## Distribution

US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE

## Key facts

- **Recall number:** Z-2255-2023
- **Recalling firm:** NeuMoDx Molecular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-24
- **Report date:** 2023-08-09

- **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-2255-2023

## Citation

> AI Analytics. FDA recall Z-2255-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2255-2023. Source: US FDA. Licensed CC0.

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