NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular… — Class II medical device recall Z-1000-2022
Ongoing recall by NeuMoDx Molecular Inc, reported 2022-05-04, distributed nationwide. Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction
| Recall number | Z-1000-2022 |
|---|---|
| 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 | 2022-02-18 |
| Classified | 2022-04-22 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, DK, ES, FI, FR, GB, HK, IT, NL, SE, SI |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10814278020274 |
| Lot numbers | 115424, 115425, 115426, 115427, 115429, 115431 |
| Model numbers | 100100, 300800, 300900 |
Product
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100
Reason for recall
Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients
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-1000-2022. 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.