Siemens epoc BGEM BUN Test Cards recalled for negative sodium measurement bias
Siemens Healthcare Diagnostics Inc. is recalling epoc BGEM BUN Test Cards from certain lots because of a negative sodium bias that may produce inaccurate results. The average measured bias was -4.4 mmol/L, with a maximum of -14 mmol/L.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II diagnostic device with identified measurement accuracy issues that could affect clinical decision-making. No illnesses or injuries have been reported. The potential for harm exists due to inaccurate test results, meeting the criteria for a high-severity recall of a risk-of-harm product without reported injury.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling epoc BGEM BUN Test Cards (Material Number 10736515) from specific lots due to a negative sodium bias that may affect the accuracy of sodium measurements.
The affected test cards may produce sodium readings that are lower than actual values. The average negative bias observed was -4.4 mmol/L, with a maximum bias of -14 mmol/L recorded at higher sodium concentrations around 150 mmol/L. All other analytes measured by the test card are performing as intended.
The recall affects 37,554 units distributed worldwide, including throughout the United States and numerous other countries. Specific affected lot numbers are identified in the FDA recall notice. Quality control fluid may not consistently detect this measurement issue depending on the bias magnitude and the frequency of quality control testing.
The recalled product
- Product
- epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- measurement-bias
- inaccurate-sodium-measurement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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