Ameditech Inc recalls Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS O

Recalled October 7, 2020 · FDA recall Z-3033-2020 · Ameditech

Hazard

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. · FDA Class II

Units

31,600 units

Sold at

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

Description

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.

Product

Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",

Manufacturer(s)

Ameditech Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →