Ameditech Inc: Medical Device Recall in 2014 - (Recall #: Z-0071-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 23, 2014

Date Posted: October 22, 2014

Recall Number: Z-0071-2015

Event ID: 69333

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.

Status: Terminated

Product Quantity: 400 kits

Code Information:

Lot No. 141012

Distribution Pattern:

Distributed in AL.

Voluntary or Mandated:

Voluntary: Firm initiated