# FDA recall Z-2477-2023

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2023-06-01.

## Product

epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

## Reason for recall

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

## Distribution

US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX  OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam

## Key facts

- **Recall number:** Z-2477-2023
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-01
- **Report date:** 2023-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2477-2023

## Citation

> AI Analytics. FDA recall Z-2477-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2477-2023. Source: US FDA. Licensed CC0.

---

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