PlainRecalls
FDA Devices Moderate Class II Terminated

DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D 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.

Reported: November 25, 2015 Initiated: October 20, 2015 #Z-0307-2016

Product Description

DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D 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.

Reason for Recall

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

Details

Recalling Firm
Ameditech Inc
Units Affected
300 units
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D 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.. Recalled by Ameditech Inc. Units affected: 300 units.
Why was this product recalled? ▼
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Moderate. Recall number: Z-0307-2016.

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