FDA-Device2018-05-09Class III
Alere iScreen Dx Urine Drug Screen Card
Ameditech Inc
Hazard
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.
Sold states
Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Affected count
828 kits (20,700 devices)
Manufactured in
9940 Mesa Rim Rd, N/A, San Diego, CA, United States
Products
Alere iScreen Dx Urine Drug Screen Card
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1542-2018Don't want to check this manually?
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