Reported Sep 6, 2017 · Terminated
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1…
Ameditech Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ameditech Inc · 9940 Mesa Rim Rd · San Diego, CA · 92121-2910
Is this the product you have?
- 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
- Lot codes and dates
P/N IS10-DXLot No. U0731
- Amount recalled
- 263Kits
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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