Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0073-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2014-09-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0073-2015
Date of alert
2014-09-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ameditech Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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