Drug recall
Inactivated macrolide-resistant Mycoplasma genitalium
FDA recall event 89887 · Class II · Microbiologics Inc
Key facts
| Event ID | 89887 |
|---|---|
| Recall numbers | Z-0955-2022 |
| Recalling firm | Microbiologics Inc |
| Product type | Devices |
| Products | Inactivated macrolide-resistant Mycoplasma genitalium |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The QC process was not adequate for the specification range. |
| Initiation date | Mar 22, 2022 |
| Report date | Apr 27, 2022 |
| Termination date | Jan 9, 2023 |
| City | Saint Cloud |
| State | MN |
| Country | United States |
| FEI number | 2150138 |
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: