NeuMoDx Cartridge — Class II medical device recall Z-1978-2021
Terminated recall by NeuMoDx Molecular Inc, reported 2021-07-07. There is a potential for false positive results when certain lots of cartridges are used in conjunction with s
| Recall number | Z-1978-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuMoDx Molecular Inc, Ann Arbor, MI, United States |
| Recall initiated | 2021-05-04 |
| Classified | 2021-06-29 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2022-06-21 |
| UPC / GTIN / UDI-DI | 10814278020274 |
| Lot numbers | 106629, 106630, 106631, 106632 |
| Model numbers | 100100 |
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.
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-1978-2021. 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.