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Terminated

Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P 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-0312-2016 · Posted None

Recalling FirmAmeditech Inc
Recall StatusTerminated
Product CodeJXM
Date Initiated2015-10-20
Date Terminated2016-11-09
Product Quantity1172 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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