Reported May 6, 2026 · Ongoing
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637
Is this the product you have?
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System
- Siemens Material Number (SMN)10736515
- Lot codes and dates
- Siemens Material Number (SMN)10736515
- UDI-DI00809708121860
- Lot numbers
01-26024-7001-26026-7001-26028-7001-26030-70 (OUS only)02-26027-8002-26028-80 (OUS only)
- Amount recalled
- 71725 (38025 US, 33700 OUS)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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