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Status Toxi Cup 13+4

Lifesign L.L.C. · Model 65C12+4 · UDI-DI 00863480002113

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

Description

Status Toxi-Cup 13 panel drug cup with 4 adulterants: AMP1000 BAR300 COC300 THC50 MAD300 MET1000 MDMA500 OPI2000 OXY100 PCP25 TCA1000 BUP10 Adulterants - CRE, pH, SG, NBP

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.