Drug recall
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the…
FDA recall event 92615 · Class II · NeuMoDx Molecular Inc
Key facts
| Event ID | 92615 |
|---|---|
| Recall numbers | Z-2255-2023 |
| Recalling firm | NeuMoDx Molecular Inc |
| Product type | Devices |
| Products | NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may… |
| Initiation date | May 24, 2023 |
| Report date | Aug 9, 2023 |
| City | Ann Arbor |
| State | MI |
| Country | United States |
| FEI number | 3010729479 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: