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Ameditech Inc recalls Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 I
Recalled September 6, 2017 · FDA recall Z-3084-2017 · Ameditech
Hazard
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. · FDA Class III
Units
263Kits
Sold at
Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Description
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.
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
Manufacturer(s)
Ameditech Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →