Reported Aug 13, 2025 · Ongoing

epoc BGEM BUN Test Card [25pk]. Material Number: 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 [25pk]
  • Material Number10736515
Lot codes and dates
  • Material Number10736515
  • GTIN00809708121860
  • Lot Numbers

    81 of 81 codes

    • 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
Amount recalled
37,554 units

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Siemens Healthcare Diagnostics Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.