Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System Recalled by Siemens Healthcare Diagnostics Inc Due to Siemens Healthcare Diagnostics Inc. has confirmed that a...

Date: September 24, 2024
Company: Siemens Healthcare Diagnostics Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics Inc directly.

Affected Products

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

Quantity: 1292 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc has 75 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report