CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report

epoc BGEM Crea Test Card for the epoc Blood Analysis System recalled

Siemens Healthcare Diagnostics is recalling epoc BGEM Crea 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

Lot, batch or date codesSiemens 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.

Quantity recalled5,207 units

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-1685-2025
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 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.

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.

Nationwide

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): 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.

Where was it sold?

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

This product is part of a recall event; the main page for the event is epoc BGEM BUN Test Card for the epoc Blood Analysis System recalled.

Reported	Class	Recall	Company	Reason	Where
7 May 2025	CLASS II	epoc BGEM BUN Test Card for the epoc Blood Analysis System recalled	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide

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