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FDAFDA · Food and drugs·Recall number Z-0301-2016

11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Published November 25, 2015 · Recall initiated: October 20, 2015

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Ameditech Inc
Distributor
Worldwide Distribution - US (nationwide) and Internationally to Australia.
Lot
142898 151145 142899
Risk classification
Class II
Area (FDA)
device
Country
United States

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