Drug recall
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of…
FDA recall event 67436 · Class II · Focus Diagnostics Inc
Key facts
| Event ID | 67436 |
|---|---|
| Recall numbers | Z-1144-2014 |
| Recalling firm | Focus Diagnostics Inc |
| Product type | Devices |
| Products | Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals. |
| Initiation date | Feb 4, 2014 |
| Report date | Mar 12, 2014 |
| Termination date | Nov 1, 2014 |
| City | Cypress |
| State | CA |
| Country | United States |
| FEI number | 2023365 |
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: