12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP 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.
FDA Recall Z-0302-2016 · Posted None
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Recalling FirmAmeditech Inc
Recall StatusTerminated
Product CodeJXM
Date Initiated2015-10-20
Date Terminated2016-11-09
Product Quantity960 units
Reason for Recall
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Firm Action
Ameditech Inc. sent an Urgent Medical Device Recall Letter to al affected customers on October 20, 2015, to inform them that Ameditech is recalling affected lots of Ameditech's Drugs of Abuse Tests because they have shown reduced reactivity for up to three of the nineteen Benzodiazepine (BZO) compounds. The letter informs customers of the actions to be taken. Customers were instructed to complete and return the customer verification form to (858) 677-0243 or scan and email to [email protected]. For questions regarding this recall call 858-535-1968.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US (nationwide) and Internationally to Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K113501AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)Ameditech, Inc. · 2011-12-05K113046AMEDITECH IMMUTEST MILTI-DRUG SCREENAmeditech, Inc. · 2011-11-10K052115FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASYFirst Check Diagnostics, LLC · 2005-12-29
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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