Drug recall
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
FDA recall event 76159 · Class II · Immuno-Mycologics, Inc
Key facts
| Event ID | 76159 |
|---|---|
| Recall numbers | Z-1109-2017 |
| Recalling firm | Immuno-Mycologics, Inc |
| Product type | Devices |
| Products | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive… |
| Initiation date | Dec 27, 2016 |
| Report date | Feb 8, 2017 |
| Termination date | Mar 8, 2017 |
| 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: