Device recall
Z-0738-2022: NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under…
FDA device recall · Class II · NeuMoDx Molecular Inc
Key facts
| Recall number (Z-number) | Z-0738-2022 |
|---|---|
| Recall event | 89675 |
| Product | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date. |
| Product code | QJR |
| Recalling firm | NeuMoDx Molecular Inc |
| Recall class | Class II |
| 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