Ameditech Inc: Medical Device Recall in 2015 - (Recall #: Z-0300-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K ; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

Product Classification:

Class II

Date Initiated: October 20, 2015

Date Posted: November 25, 2015

Recall Number: Z-0300-2016

Event ID: 72471

Reason for Recall:

Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

Status: Terminated

Product Quantity: 100 units

Code Information:

150503 144376

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to Australia.

Voluntary or Mandated:

Voluntary: Firm initiated