# FDA recall Z-3030-2020

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

## Product

Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description):   X11-IS12-DX /	"Alere iScreen"  Dx Multi-Drugs of Abuse Dip Test  12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000",    X11-IS12-DX /	"Alere iScreen"  Dx Multi-Drugs of Abuse Dip Test  12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000",    X11-IS10BUP-DX /	"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test  AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100",    X11-IS12-DX /	"Alere iScreen"  Dx Multi-Drugs of Abuse Dip Test  12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000",    X11-IS10BUP-DX /	"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test  AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100",    X11-IS10BUP-DX/ "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test  AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP

## 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-3030-2020
- **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-3030-2020

## Citation

> AI Analytics. FDA recall Z-3030-2020. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-3030-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*