Drug recall
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched…
FDA recall event 77702 · Class III · Ameditech Inc
Key facts
| Event ID | 77702 |
|---|---|
| Recall numbers | Z-3084-2017 |
| Recalling firm | Ameditech Inc |
| Product type | Devices |
| Products | Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly. |
| Initiation date | Jun 26, 2017 |
| Report date | Sep 6, 2017 |
| Termination date | Aug 6, 2019 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3003789989 |
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: