Drug recall
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal…
FDA recall event 85368 · Class II · Immuno-Mycologics, Inc
Key facts
| Event ID | 85368 |
|---|---|
| Recall numbers | Z-2301-2020 |
| Recalling firm | Immuno-Mycologics, Inc |
| Product type | Devices |
| Products | Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | False positive results due to potential contamination of reagent. |
| Initiation date | Nov 4, 2019 |
| Report date | Jun 17, 2020 |
| Termination date | May 27, 2022 |
| City | Norman |
| State | OK |
| Country | United States |
| FEI number | 1627497 |
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: