CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report
epoc BGEM BUN Test Card for the epoc Blood Analysis System recalled
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Card for the epoc Blood Analysis System, distributed nationwide in the US. The recall was initiated on 19 Mar 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-1684-2025
- FDA event ID
- 96539
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2025
- FDA classified
- 29 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 19 Mar 2025 | Recall initiated by company | |
| 29 Apr 2025 | Classified by FDA | +41 days |
| 7 May 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
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
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 (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Where it was distributed
Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Malaysia, Mali, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam.
Questions about this recall
Why was it recalled?
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Which lots are affected?
Siemens Material Number (SMN): 10736515; Udi-DI: 00809708121860; Lot Numbers: All lot numbers with prefix (xx) 02 or 12; epoc Software Version and Senor Configuration: epoc Host SW V3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Where was it sold?
Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Malaysia, Mali, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam.
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.
Other products in this recall event
1 other product · FDA event 96539| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | epoc BGEM Crea Test Card for the epoc Blood Analysis System recalled | Siemens Healthcare Diagnostics | Device Malfunction | Nationwide |
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