CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
epoc BGEM BUN Test Card []. Material Number recalled
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Card []. Material Number: 10736515, distributed nationwide in the US. The recall was initiated on 7 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2272-2025
- FDA event ID
- 97180
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jul 2025
- FDA classified
- 5 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 Jul 2025 | Recall initiated by company | |
| 5 Aug 2025 | Classified by FDA | +29 days |
| 13 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Where it was distributed
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.
Questions about this recall
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.
Which lots are affected?
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.
Where was it sold?
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 should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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