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.
FDA Recall Z-0071-2015 · Posted 2014-10-16
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Recalling FirmAmeditech Inc
Recall StatusTerminated
Product CodeDKZ
Date Initiated2014-09-23
Date Terminated2015-02-27
Product Quantity400 kits
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.
Firm 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 [email protected].
Root Cause
Labeling Change Control
Distribution Pattern
Distributed in AL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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