Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W
FDA Recall Z-0513-2016 · Posted None
Advertisement
Recalling FirmAmeditech Inc
Recall StatusTerminated
Product CodeJXM
Date Initiated2015-11-16
Date Terminated2016-11-09
Product Quantity144 kits
Reason for Recall
Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
Firm Action
A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution.
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.
Advertisement