—#130242

Product

ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. 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 product code: DKZ — Enzyme Immunoassay, Amphetamine
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K113046
Affected lot / code info: Lot No. 141001

Why it was recalled

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Ameditech Inc
Address: 9940 Mesa Rim Rd, San Diego, California 92121-2910

Distribution

Distribution pattern: Distributed in AL.

Timeline

Recall initiated: 2014-09-23
Posted by FDA: 2014-10-16
Terminated: 2015-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130242. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.