# FDA recall Z-3051-2020

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

## Product

Drug Screening Component: Uncut Sheets  Part Number/ Description/ LOT Number  100163/ EDI OPI (300) Uncut Sheet-Card /187876,  100195/ EDI PPX Uncut Sheet-Card/ 187877,  160130/ EDI COC Uncut Sheet-Cup/ 188168,  160180/ EDI PCP Uncut Sheet-Cup/ 189027,  160140/ EDI THC Uncut Sheet Cup /189028,  160170/ EDI BZO Uncut Sheet-Cup/ 189081,  160120/ EDI MET1000 Uncut Sheet-Cup/ 189082,  160160/ EDI OPI2000 Uncut Sheet-Cup	/ 189123,  160130/ EDI COC Uncut Sheet-Cup/ 189124,  160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166,  160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191,  160110/ EDI AMP Uncut Sheet-Cup/ 189371,  160140/ EDI THC Uncut Sheet Cup/ 189372,  160123/ EDI MET(300) Uncut Sheet-Cup/ 189425,  160170/ EDI BZO Uncut Sheet-Cup/ 189426,  100163/ EDI OPI (300) Uncut Sheet-Card/ 189456,  160170/ EDI BZO Uncut Sheet-Cup/ 189565,  160180/ EDI PCP Uncut Sheet-Cup/ 189601,  160125/ EDI MET(500) Uncut Sheet-Cup/ 189748,  160130/ EDI COC Uncut Sheet-Cup/ 189786,  160160/ EDI OPI2000 Uncut Sheet-Cup	/ 

## 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-3051-2020
- **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-3051-2020

## Citation

> AI Analytics. FDA recall Z-3051-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-3051-2020. Source: US FDA. Licensed CC0.

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