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U.S. Department of Health and Human Services

Class 2 Device Recall DrugCheck

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 Class 2 Device Recall DrugChecksee related information
Date Initiated by FirmOctober 20, 2015
Create DateNovember 18, 2015
Recall Status1 Terminated 3 on November 09, 2016
Recall NumberZ-0305-2016
Recall Event ID 72471
510(K)NumberK052115 K113046 K113501 
Product Classification Enzyme immunoassay, benzodiazipine - Product Code JXM
ProductDrugCheck Pipette 10 Drug Test, Item No. 41025 DC 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 142512 
Recalling Firm/
Manufacturer		 Ameditech Inc
9940 Mesa Rim Rd
San Diego CA 92121-2910
For Additional Information Contact
858-535-1968
Manufacturer Reason
for Recall		Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAmeditech 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 Commerce70 units
DistributionWorldwide Distribution - US (nationwide) and Internationally to Australia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JXM
510(K)s with Product Code = JXM
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