Date Initiated by Firm | September 23, 2014 |
Date Posted | October 16, 2014 |
Recall Status1 |
Terminated 3 on February 27, 2015 |
Recall Number | Z-0072-2015 |
Recall Event ID |
69333 |
510(K)Number | K113046 |
Product Classification |
Enzyme immunoassay, amphetamine - Product Code DKZ
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Product | ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M.
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. 140874 |
Recalling Firm/ Manufacturer |
Ameditech Inc 9940 Mesa Rim Rd San Diego CA 92121-2910
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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 | 80 kits |
Distribution | Distributed in AL. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = DKZ
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