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U.S. Department of Health and Human Services

Class 2 Device Recall ArcPoint Labs 5 Panel Dip Drug Screen

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  Class 2 Device Recall ArcPoint Labs 5 Panel Dip Drug Screen see related information
Date Initiated by Firm September 23, 2014
Date Posted October 16, 2014
Recall Status1 Terminated 3 on February 27, 2015
Recall Number Z-0071-2015
Recall Event ID 69333
510(K)Number K113046  
Product Classification Enzyme immunoassay, amphetamine - Product Code DKZ
Product ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M.

The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
Code Information Lot No. 141012
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 the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.
FDA Determined
Cause 2		 Labeling Change Control
Action A customer notification letter dated 9/23/14 was sent to all customers who purchased the ArcPoint Labs Dip Drug Screen Dip Card. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the Verification Form. Customers with questions are instructed to contact Ameditech at (858) 805-8714 or email at amd.complaint@alere.com.
Quantity in Commerce 400 kits
Distribution Distributed in AL.
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 = DKZ and Original Applicant = AMEDITECH, INC.
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