# FDA recall Z-2272-2025

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2025-07-07.

## Product

epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

## Reason for recall

Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The  observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bahrain, Bolivia, Brazil, Canada, Canary Islands, Chile, Croatia, Denmark, Ecuador, Estonia, France, Fren. Polynesia, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Caledonia, Paraguay, Philippines, Poland, Portugal, Qatar, Rep. Korea (S), Romania, Russian Fed., San Marino, Slovakia, Slovenia, South Africa, Spain, Srilanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, Unit.Arab Emir., United Kingdom, Uruguay, Japan.

## Key facts

- **Recall number:** Z-2272-2025
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-07
- **Report date:** 2025-08-13

- **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-2272-2025

## Citation

> AI Analytics. FDA recall Z-2272-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2272-2025. Source: US FDA. Licensed CC0.

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