# FDA recall Z-3034-2020

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

## Product

Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description):    MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect¿ II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300",    MF20/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: MTD300",  MF21/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: TCA1000,  MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100",  MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100",  MF18/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BZO300,  MF18/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BZO300",    QF12/ "Fastect¿ II Drug Screen Dipstick Test 4 Drug Detection: THC50+COC300+OPI300+MET500",    MF10/ "Fastect¿ II Drug Screen Dipstick Test THC50",   MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10",  MF16 /"Fastect¿ II Drug Screen Dip

## 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-3034-2020
- **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-3034-2020

## Citation

> AI Analytics. FDA recall Z-3034-2020. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-3034-2020. Source: US FDA. Licensed CC0.

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