PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: September 6, 2017 Initiated: June 26, 2017 #Z-3084-2017

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.

Details

Recalling Firm
Ameditech Inc
Units Affected
263Kits
Distribution
Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Ameditech Inc. Units affected: 263Kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2017. Severity: Low. Recall number: Z-3084-2017.

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