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U.S. Department of Health and Human Services

Class 3 Device Recall EDI BZO

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 Class 3 Device Recall EDI BZOsee related information
Date Initiated by FirmNovember 16, 2015
Create DateDecember 24, 2015
Recall Status1 Terminated 3 on November 09, 2016
Recall NumberZ-0501-2016
Recall Event ID 72651
510(K)NumberK052115 K113046 K113501 
Product Classification Enzyme immunoassay, benzodiazipine - Product Code JXM
ProductEDI BZO Uncut Sheet - Cup*, Item No. 160170
Code Information 141260 141294 141909 141925 142074 142243 142428 142614 142712 142911 144555 151925 152003 152223 152498 152723 152897 153311 153559 153818 154184 152103 
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		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA 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 amt.fieldaction@alere.com.
Quantity in Commerce45,584 kits
DistributionNationwide Distribution.
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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