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U.S. Department of Health and Human Services

Class 3 Device Recall CLIAwaived

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  Class 3 Device Recall CLIAwaived see related information
Date Initiated by Firm November 16, 2015
Create Date December 24, 2015
Recall Status1 Terminated 3 on November 09, 2016
Recall Number Z-0491-2016
Recall Event ID 72651
510(K)Number K052115  K113046  K113501  
Product Classification Enzyme immunoassay, benzodiazipine - Product Code JXM
Product CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5










Code Information 142709 142840 143008 143571 143665 144217 152234 152379 
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
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 amt.fieldaction@alere.com.
Quantity in Commerce 10,320 kits
Distribution Nationwide Distribution.
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
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