Device recall
Z-2093-2023: NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of…
FDA device recall · Class III · NeuMoDx Molecular Inc
Key facts
| Recall number (Z-number) | Z-2093-2023 |
|---|---|
| Recall event | 92490 |
| 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 |
| Product code | QJR |
| Recalling firm | NeuMoDx Molecular Inc |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 3010729479 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database