FDA-Device2014-10-22Class II

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.

Ameditech Inc
Hazard

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.

Sold states
Distributed in AL.
Affected count
400 kits
Manufactured in
9940 Mesa Rim Rd, N/A, San Diego, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2015

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