Class II — Potential Health Hazard

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

Siemens epoc BGEM Test Card-In vitro diagnostic device for the Recalled by Siemens Healthcare Diagnostics Inc Due to Sporadically inconsistent discrepant (low bias) glucose results on...

Date: August 28, 2020
Company: Siemens Healthcare Diagnostics Inc
Status: Terminated
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

Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382

Quantity: 463 boxes (50 test cards/box )

Why Was This Recalled?

Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.

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