Device product
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
Z-3084-2017
Product summary
- Firm
- Ameditech Inc
- Event
- Event 77702
- Status
- Terminated
- Classification
- Class III
- Quantity
- 263Kits
- Official record key
device-enforcement:Z-3084-2017
Official wording
Reason: 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.
Code information: P/N IS10-DX; Lot No. U0731
Distribution pattern: Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Derived failure modes
-
Unknown
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.