Device recall
Z-1000-2022: NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems…
FDA device recall · Class II · NeuMoDx Molecular Inc
Key facts
| Recall number (Z-number) | Z-1000-2022 |
|---|---|
| Recall event | 89846 |
| 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… |
| 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