epoc BGEM BUN Test Card recall (Siemens Healthcare Diagnostics Inc)
Medical deviceClass IIOngoing
Summary: Siemens Healthcare Diagnostics Inc is recalling 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.
What is being recalled
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.
How to tell if yours is affected
Siemens Material Number (SMN): 10736515; UDI-DI: 00809708121860; Lot numbers: 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70 (OUS only), 02-26027-80, 02-26028-80 (OUS only);
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2005-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 2, 2026 |
| Reported | May 6, 2026 |
| Company | Siemens Healthcare Diagnostics Inc |
| Company location | Norwood, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 71725 (38025 US, 33700 OUS) |
More recalls from Siemens Healthcare Diagnostics Inc · all medical device recalls · recalls from April 2026