Medical Device Recall: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Siemens Healthcare Diagnostics Inc · April 2, 2026
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.
States Affected
NATIONWIDE
Quantity Affected
71725 (38025 US, 33700 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2005-2026
Status: ongoing
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