Ameditech Inc: Medical Device Recall in 2015 - (Recall #: Z-0539-2016)

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:

ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W

Product Classification:

Class III

Date Initiated: November 16, 2015

Date Posted: December 30, 2015

Recall Number: Z-0539-2016

Event ID: 72651

Reason for Recall:

Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

Status: Terminated

Product Quantity: 743 kits

Code Information:

142153 142594 143825 144227 152005 152972

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated