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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 Dipcardsee related information
Date Initiated by FirmFebruary 15, 2019
Date PostedDecember 17, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-0692-2020
Recall Event ID 84239
510(K)NumberK022355 
Product Classification Enzyme immunoassay, opiates - Product Code DJG
ProductQuickTox 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 ContactAngela Occhionero
858-805-8943
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		Labeling mix-ups
ActionOn 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 Commerce3400 units (136 kits)
DistributionUS - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None
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 = DJG
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