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Alere iScreen Dx

Instant Technologies, Inc. · Model IS12-DX · UDI-DI 00817405020171

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1
510(k) clearances
1
Adverse events
3
Recalls
7
Facilities

Description

Urine Drug Screen Card for detection of 12 drugs, Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine and Tricyclic Antidepressants, CLIA Waived

Recalls

DateFirmReason
2017-12-15Ameditech IncThe 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.
2017-06-26Ameditech IncThe 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
2003-11-17Abbott Health Products, Inc.Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.