Ameditech Inc: Medical Device Recall in 2015 - (Recall #: Z-0312-2016)

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:

Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P 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-0312-2016

Event ID: 72471

Reason for Recall:

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

Status: Terminated

Product Quantity: 1172 units

Code Information:

144380 144564 150505 150908 151538 142098 144103 150313 150909 141645 144563 150483 151337 142076 142966 144263 151540

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated