Drug recall
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i…
FDA recall event 71059 · Class II · Alere Scarborough, Inc. dba Binax, Inc.
Key facts
| Event ID | 71059 |
|---|---|
| Recall numbers | Z-1677-2015 |
| Recalling firm | Alere Scarborough, Inc. dba Binax, Inc. |
| Product type | Devices |
| Products | Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit. |
| Initiation date | Apr 22, 2015 |
| Report date | Jun 3, 2015 |
| Termination date | Jan 14, 2016 |
| City | Scarborough |
| State | ME |
| Country | United States |
| FEI number | 1221359 |
At a glance
- 1–9 Products in this recall
- 10–99 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: