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 with epoc Host SW v3.37.3 Recalled by Siemens Healthcare Diagnostics Inc Due to There is potential for discrepant high glucose results...

Date: June 1, 2023
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 with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

Quantity: 3201 ea

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 26 states: AL, AZ, AR, CA, CO, DE, FL, ID, IL, IA, KS, KY, LA, MI, MN, MO, NH, NY, NC, ND, OH, OK, SC, SD, TX, DC

Affected (26 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