# FDA recall Z-3031-2020

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

## Product

Alere iCup Drug Detection (AMT Item Number/ AMT Description):    I-DXA-10/	"Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC  Bl, Cr, Ni, pH, SG",    I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration  AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA  Bl, Cr, Ni, pH, SG",    I-DXA-1127-023-N	"Alere" iCup¿ Dx Drugs of Abuse Test   (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO 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-3031-2020
- **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-3031-2020

## Citation

> AI Analytics. FDA recall Z-3031-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-3031-2020. Source: US FDA. Licensed CC0.

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