Drug recall
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model…
FDA recall event 88099 · Class II · NeuMoDx Molecular Inc
Key facts
| Event ID | 88099 |
|---|---|
| Recall numbers | Z-1978-2021 |
| Recalling firm | NeuMoDx Molecular Inc |
| Product type | Devices |
| Products | NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays. |
| Initiation date | May 4, 2021 |
| Report date | Jul 7, 2021 |
| Termination date | Jun 21, 2022 |
| 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: