Ameditech Inc: Medical Device Recall in 2020 - (Recall #: Z-3042-2020)

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:

ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO

Product Classification:

Class II

Date Initiated: August 18, 2020

Date Posted: October 7, 2020

Recall Number: Z-3042-2020

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: 51,075 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