# FDA recall Z-1256-2019

> **Lin-Zhi International Inc** · Class III · device recall initiated 2019-01-11.

## Product

Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit)    Product Usage:  Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue  was used while producing R2 of the defective lot.

## Reason for recall

Shelf life of the product may be reduced due to degradation of the assay.

## Distribution

US Nationwide Distribution in the states of CA, MA, GA, KY, NC, MI, MD, NC, CT, AZ SC, TN, OR

## Key facts

- **Recall number:** Z-1256-2019
- **Recalling firm:** Lin-Zhi International Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-11
- **Report date:** 2019-05-08
- **Termination date:** 2021-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1256-2019

## Citation

> AI Analytics. FDA recall Z-1256-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1256-2019. Source: US FDA. Licensed CC0.

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