Ameditech Inc: Medical Device Recall in 2020 - (Recall #: Z-3035-2020)

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:

Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",

Product Classification:

Class II

Date Initiated: August 18, 2020

Date Posted: October 7, 2020

Recall Number: Z-3035-2020

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: 31,800 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