Siemens Healthcare Diagnostics Inc: Epoc Bgem Bun Test Card (25 Pk) For The Epoc Blood Analysis System; Siemens Material Number (smn): 10736515

Recall Summary Siemens is recalling epoc BGEM BUN Test Cards (25-pack) used with the epoc Blood Analysis System because they can produce inaccurate pH and carbon dioxide measurements in blood samples. These incorrect results could lead to unnecessary treatment for conditions that don't exist or cause doctors to miss actual acid-base imbalances in patients' blood. The affected test cards were distributed nationwide in the US and in several other countries.

Recalling firm

Siemens Healthcare Diagnostics Inc

Product

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

Reason

Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.

Classification

Class II

Category

medical device recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-04-02

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/d6345d84-9bb5-4197-b100-13b6b1e95d3f