Z-1542-2018 Class III Terminated
FDA device recall Z-1542-2018 was initiated by Ameditech Inc on December 15, 2017 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated February 11, 2019). Affected quantity: 828 kits (20,700 devices).
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- December 15, 2017
- Termination Date
- February 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 828 kits (20,700 devices)
Product Description
Alere iScreen Dx Urine Drug Screen Card
Reason for Recall
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.
Distribution Pattern
Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Code Information
Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.