# FDA recall Z-1599-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-02-14.

## Product

Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

## Reason for recall

The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.

## Distribution

Domestic distribution nationwide. Foreign distribution to Australia, Austria, Bahamas, Belgium, Canada, Curacao, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kenya, Latvia, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Uruguay, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-1599-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-14
- **Report date:** 2020-04-01
- **Termination date:** 2024-02-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1599-2020

## Citation

> AI Analytics. FDA recall Z-1599-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1599-2020. Source: US FDA. Licensed CC0.

---

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