Device product
Alere iScreen Dx Urine Drug Screen Card
Z-1542-2018
Product summary
- Firm
- Ameditech Inc
- Event
- Event 79549
- Status
- Terminated
- Classification
- Class III
- Quantity
- 828 kits (20,700 devices)
- Official record key
device-enforcement:Z-1542-2018
Official wording
Reason: The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
Code information: Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.
Distribution pattern: Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Derived failure modes
-
Unknown
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.