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QTEST 11 (25 pack)

MEDIMPEX UNITED, INC · Model DOA-11Ca · UDI-DI 10864040000331

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

Description

Qtest 11 (25 Pack) - AMP 1000, BAR 300, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50

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.