PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 22, 2014 Initiated: September 23, 2014 #Z-0073-2015

Product Description

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.

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.

Details

Recalling Firm
Ameditech Inc
Units Affected
320 kits
Distribution
Distributed in AL.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ameditech Inc. Units affected: 320 kits.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 22, 2014. Severity: Moderate. Recall number: Z-0073-2015.