FDA Medical devices recall ·
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515 recall
- Recall number
- Z-2272-2025
- Date
- (initiated July 7, 2025)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
2 Edgewater Dr, Norwood, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 37,554 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Why was it recalled?
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Material Number: 10736515. GTIN: 00809708121860. Lot Numbers: 02-25095-30, 02-25096-30, 02-25098-30, 02-25099-30, 02-25100-30, 02-25101-30, 02-25102-30, 02-25103-30, 02-25105-30, 02-25111-30, 02-25112-30, 02-25114-30, 02-25115-30, 02-25116-30, 02-25117-30, 02-25119-30, 02-25121-30, 02-25122-30, 02-25124-30, 02-25096-40, 02-25097-40, 02-25098-40, 02-25099-40, 02-25101-40, 02-25102-40, 02-25105-40, 02-25106-40, 02-25121-40, 02-25122-40, 02-25124-40, 02-25125-40, 02-25096-50, 02-25098-50, 02-25099-50, 02-25100-50, 02-25102-50, 02-25103-50, 02-25105-50, 02-25107-50, 02-25108-50, 02-25111-50, 02-25112-50, 02-25113-50, 02-25114-50, 02-25115-50, 02-25119-50, 02-25120-50, 12-25096-60, 12-25097-60, 12-25098-60, 12-25100-60, 12-25101-60, 12-25102-60, 12-25103-60, 12-25111-60, 02-25112-60, 02-25113-60, 02-25114-60, 02-25115-60, 02-25116-60, 02-25117-60, 02-25118-60, 02-25120-60, 02-25121-60, 02-25122-60, 02-25123-60, 02-25124-60, 02-25099-70, 02-25101-70, 02-25104-70, 02-25105-70, 02-25107-70, 02-25108-70, 02-25110-70, 02-25111-70, 02-25112-70, 02-25113-70, 02-25115-70, 02-25116-70, 02-25118-70, 02-25120-70.
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bahrain, Bolivia, Brazil, Canada, Canary Islands, Chile, Croatia, Denmark, Ecuador, Estonia, France, Fren. Polynesia, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Caledonia, Paraguay, Philippines, Poland, Portugal, Qatar, Rep. Korea (S), Romania, Russian Fed., San Marino, Slovakia, Slovenia, South Africa, Spain, Srilanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, Unit.Arab Emir., United Kingdom, Uruguay, Japan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2272-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.