Ameditech Inc: Medical Device Recall in 2020 - (Recall #: Z-3036-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO ADULTERATION", IMCA-8CM5 /"ImmuTest Drugs of Abuse Cup (OXY100/MDMA500)+(PCP25/AMP1000)+COC150+MET500+OPI2000+THC50 with Cr, Ni, pH, Bl, S.G."

Product Classification:

Class II

Date Initiated: August 18, 2020

Date Posted: October 7, 2020

Recall Number: Z-3036-2020

Event ID: 86335

Reason for Recall:

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Status: Terminated

Product Quantity: 27,375 units

Code Information:

ALL Lots Within Expiry

Distribution Pattern:

US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

Voluntary or Mandated:

Voluntary: Firm initiated