The Recall Desk
ModerateFDA (Devices)·Z-1685-2025·Announced 2025-05-07

epoc BGEM Crea Test Card for Blood Analysis System recalled

Siemens Healthcare Diagnostics is recalling epoc BGEM Crea Test Card (25 pk) units due to discrepant high pH results in samples with higher injection volumes. The recall affects 5,207 units distributed nationwide and internationally.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—discrepant high pH results—represents a measurement accuracy issue that could affect diagnostic interpretation, warranting precautionary action but not rising to High or above since no adverse clinical outcomes are reported.

Plain-English summary

Siemens Healthcare Diagnostics Inc is recalling epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System. The recall applies to Siemens Material Number 10736382 with specific software versions (epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11) and Sensor Configuration 45.n.

The recall was initiated due to the occurrence of discrepant high pH results in samples introduced with higher injection volumes when using the affected sensor configuration. A total of 5,207 units have been recalled.

The affected test cards were distributed nationwide in the United States and internationally to 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, and Vietnam.

Lot numbers with prefixes 00 or 06 are affected. Facilities using these test cards should verify their lot numbers and contact Siemens Healthcare Diagnostics Inc for instructions on return or replacement.

The recalled product

Product
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.
Manufacturer
Siemens Healthcare Diagnostics Inc
Category
Medical Device — Diagnostic Test Card / In Vitro Diagnostic
Hazard
  • measurement-error
  • pH-discrepancy

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 (6)

  • 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.

Distribution

Distributed nationwide across the United States.

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