Z-3084-2017 Class III Terminated
FDA device recall Z-3084-2017 was initiated by Ameditech Inc on June 26, 2017 and is designated Class III. 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. The recall status is terminated (terminated August 6, 2019). Affected quantity: 263Kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- June 26, 2017
- Termination Date
- August 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 263Kits
Product Description
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 that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
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.
Distribution Pattern
Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Code Information
P/N IS10-DX; Lot No. U0731