NeuMoDx Cartridge-used for extraction — Class II medical device recall Z-2255-2023
Ongoing recall by NeuMoDx Molecular Inc, reported 2023-08-09, distributed nationwide. Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the man
| Recall number | Z-2255-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuMoDx Molecular Inc, Ann Arbor, MI, United States |
| Recall initiated | 2023-05-24 |
| Classified | 2023-07-28 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 20,016 cartridges |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10814278020274 |
| Lot numbers | 117514, 117524, 117528 |
| Model numbers | 100100 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2255-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.