Drug recall
Alere Determine HIV-1/2 Ag/Ab Combo Controls, For In vitro Diagnostic PN: 7D2628
FDA recall event 70489 · Class III · ORGENICS LTD
Key facts
| Event ID | 70489 |
|---|---|
| Recall numbers | B-0423-15 |
| Recalling firm | ORGENICS LTD |
| Product type | Biologics |
| Products | Alere Determine HIV-1/2 Ag/Ab Combo Controls, For In vitro Diagnostic PN: 7D2628 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Alere Determine HIV-1/2 Ag/Ab Combo Controls, with a decrease in the activity of the HIV-1 p24 Antigen Control solution, were distributed. |
| Initiation date | Feb 13, 2015 |
| Report date | Mar 11, 2015 |
| Termination date | Sep 10, 2015 |
| City | Yavne |
| Country | Israel |
| FEI number | 3008754095 |
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: