# FDA recall Z-3042-2020

> **Ameditech Inc** · Class II · device recall initiated 2020-08-18.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-3042-2020
- **Recalling firm:** Ameditech Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-18
- **Report date:** 2020-10-07
- **Termination date:** 2024-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3042-2020

## Citation

> AI Analytics. FDA recall Z-3042-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3042-2020. Source: US FDA. Licensed CC0.

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