Alere iScreen Dx Urine Drug Screen Card
FDA Recall Z-1542-2018 · Posted None
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Recalling FirmAmeditech Inc
Recall StatusTerminated
Product CodeLFH
Date Initiated2017-12-15
Date Terminated2019-02-11
Product Quantity828 kits (20,700 devices)
Reason for Recall
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.
Firm Action
Customers were notified on about 12/15/2017. Instructions included to become aware of the recall so as to relay the information to customers with questions.
Root Cause
Labeling Change Control
Distribution Pattern
Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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