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U.S. Department of Health and Human Services

Class 3 Device Recall QuickTox Drug Screen Dipcard

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  Class 3 Device Recall QuickTox Drug Screen Dipcard see related information
Date Initiated by Firm February 15, 2019
Create Date December 17, 2019
Recall Status1 Completed
Recall Number Z-0692-2020
Recall Event ID 84239
510(K)Number K022355  
Product Classification Enzyme immunoassay, opiates - Product Code DJG
Product QuickTox 5 Panel Drug Screen DipCard
Code Information Catalog Number: QT11 Lot Number: 188787
Recalling Firm/
Manufacturer
Ameditech Inc
9940 Mesa Rim Rd
San Diego CA 92121-2910
For Additional Information Contact Angela Occhionero
858-535-8943
Manufacturer Reason
for Recall
Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action On February 15, 2019, the firm sent a "FIELD CORRECTIVE ACTION NOTIFICATTION" via email (read receipt requested), and/or via certified mail with delivery tracking to its customers informing them of mixed products, QuickTox 5 Panel Drugs Screen Dipcard, part number QT11 with lot number 188787 containing Alere iScreen Drugs of Abuse Dip Test, part number X11-IS10-22015-DX lot number 188744. Customer are being requested to return the affected products and if products were further distributed customers are to notify those customers and request for return of affected products. In addition, all customers receiving the notice are asked to complete and return the included "Customer Verification Form" via fax 888-340-4029.
Quantity in Commerce 3400 units (136 kits)
Distribution US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None
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.
510(K) Database 510(K)s with Product Code = DJG and Original Applicant = BRANAN MEDICAL CORP.
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