Siemens epoc Blood Test Cards: Discrepant High pH Results Risk
Siemens recalls epoc BGEM BUN Test Cards (25 pack) with specific software and sensor settings that may cause inaccurate high pH results in blood tests.
Lower-risk recall
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Contact the company
What happened, in plain English
Siemens is recalling epoc BGEM BUN Test Cards (25 pack) that may give false high pH results when used with certain software versions and sensor configurations. This could lead to incorrect blood test interpretations, but the risk is not immediately dangerous to users. Read more at govinfonow.com/recall/52603-siemens-epoc-blood-test-cards-discrepant-high-ph-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/52603-siemens-epoc-blood-test-cards-discrepant-high-ph-results-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1684-2025
Cite this page
“Siemens epoc Blood Test Cards: Discrepant High pH Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52603-siemens-epoc-blood-test-cards-discrepant-high-ph-results-risk. Based on FDA recall #Z-1684-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1684-2025%22&limit=1).
Why it’s dangerous
The test cards may produce inaccurate high pH readings when used with higher injection volumes in the epoc sensor configuration 45.n. This happens with specific software versions and sensor settings, which could lead to incorrect blood test interpretations.
Who’s affected
Users of the epoc Blood Analysis System with the specific test cards and software versions listed in the recall. Laboratory staff and healthcare providers are most at risk due to potential for inaccurate test results.
How to tell if you have this one
Check for the Siemens Material Number (SMN) 10736515, software versions epoc Host SW v3.41.2 and epoc NXS SW v4.14.9 or 4.14.11, and sensor configuration 45.n. The test cards were sold with lot numbers starting with '02' or '12' in the specific software versions.
- Brand
Siemens Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1684-2025 | 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.; 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. | 264,252 units |
| Z-1685-2025 | epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.; Siemens Material Number (SMN): 10736382; Udi-DI: 00809708072254; Lot Numbers: All lot numbers with prefix (xx) 00 or 06; 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. | 5,207 units |
What to do — step by step
Check Software Versions
Verify your epoc Blood Analysis System software versions match the specific versions listed in the recall.
Review Sensor Configuration
Ensure your sensor configuration is set to 45.n as specified in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these test cards immediately?
No, the recall does not require immediate discontinuation. The risk is low and only affects specific software and sensor configurations.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1684-2025 (March 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1684-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.