NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection… — Class III medical device recall Z-2093-2023
Ongoing recall by NeuMoDx Molecular Inc, reported 2023-07-12, distributed nationwide. Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the t
| Recall number | Z-2093-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeuMoDx Molecular Inc, Ann Arbor, MI, United States |
| Recall initiated | 2023-05-15 |
| Classified | 2023-07-05 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,086 test |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10814278021264 |
| Lot numbers | 123909 |
| Model numbers | 300800 |
| Expiration dates | 2023-12-08 |
Product
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800
Reason for recall
Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.
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-2093-2023. 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.