Reported May 9, 2018 · Terminated
Alere iScreen Dx Urine Drug Screen Card
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
- Lot codes and dates
Part No. X11-IS10-DxLot No. 173351173686174055176002
- Amount recalled
- 828 kits (20,700 devices)
Where it was sold
Why it was recalled
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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