FDA recall, , Moderate risk
Siemens Epoc BGEM BUN Test Cards
The affected product can result in discrepant low pH and measured Total Carbon Dioxide results.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics Inc of Norwood, Massachusetts began a recall on April 2, 2026, of its epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, with Siemens Material Number (SMN) 10736515. The FDA added the recall to its Enforcement Report on April 29, 2026, and the weekly enforcement report on May 6, 2026.
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 or missed diagnosis of alkalosis.
The recall covers 71725 test cards, with 38025 distributed in the US and 33700 outside the US. Distribution was worldwide, including US nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, and Mexico.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
epoc Bgem BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
- UDI-DI
- 10736515
- 00809708121860
- Lot code
- 01-26024-70
- 01-26026-70
- 01-26028-70
- 01-26030-70
- 02-26027-80
- 02-26028-80
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.
- Company
- Siemens Healthcare Diagnostics IncNorwood, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98680
- Recall number
- Z-2005-2026
- Quantity recalled
- 71725 (38025 US, 33700 OUS)
All recalls from Siemens Healthcare Diagnostics Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
