# FDA recall Z-3036-2020

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

## Product

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."

## 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-3036-2020
- **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-3036-2020

## Citation

> AI Analytics. FDA recall Z-3036-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3036-2020. Source: US FDA. Licensed CC0.

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