Siemens Healthcare Diagnostics Inc. is recalling approximately 269,459 epoc BGEM BUN and Crea Test Cards used with the epoc Blood Analysis System. These test cards are being recalled because they can produce inaccurately high pH results when samples are introduced with higher injection volumes. No injuries or incidents have been reported to date, but the manufacturer has voluntarily initiated this recall to ensure patient safety.
Inaccurate pH results can lead to incorrect medical diagnoses or treatment decisions. A falsely high pH reading may cause healthcare providers to miss underlying medical conditions or provide inappropriate treatments.
Affected software/sensor configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Affected software/sensor configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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