# FDA recall Z-0286-2025

> **Siemens Healthcare Diagnostics Inc** · Class II · device recall initiated 2024-09-24.

## Product

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

## Reason for recall

Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 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.    One customer complaint has been associated with this issue. No adverse events have been reported.    All affected lots have recently expired before the issuance of the recall.

## Distribution

US Nationwide. Canada.

## Key facts

- **Recall number:** Z-0286-2025
- **Recalling firm:** Siemens Healthcare Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-24
- **Report date:** 2024-11-13

- **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-0286-2025

## Citation

> AI Analytics. FDA recall Z-0286-2025. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-0286-2025. Source: US FDA. Licensed CC0.

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