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U.S. Department of Health and Human Services

Class 2 Device Recall DrugSmart

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  Class 2 Device Recall DrugSmart see related information
Date Initiated by Firm October 20, 2015
Create Date November 18, 2015
Recall Status1 Terminated 3 on November 09, 2016
Recall Number Z-0308-2016
Recall Event ID 72471
510(K)Number K052115  K113046  K113501  
Product Classification Enzyme immunoassay, benzodiazipine - Product Code JXM
Product DrugSmart 11 Test Cup, Item No. 61127D;
DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D;
DrugSmart 9 Test Cup (BUP), Item No. 60960D;
DrugSmart Cup 10, Item No. 61093D-3C

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.

Code Information 140770 142294 151050 151527 142527 140998 142526 150596 151122 151196 
Recalling Firm/
Ameditech Inc
9940 Mesa Rim Rd
San Diego CA 92121-2910
For Additional Information Contact
Manufacturer Reason
for Recall
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
FDA Determined
Cause 2
Nonconforming Material/Component
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 amt.fieldaction@alere.com. For questions regarding this recall call 858-535-1968.
Quantity in Commerce 1220 units
Distribution Worldwide Distribution - US (nationwide) and Internationally to Australia.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXM and Original Applicant = AMEDITECH, INC.
510(K)s with Product Code = JXM and Original Applicant = FIRST CHECK DIAGNOSTICS LLC