Siemens Healthcare Diagnostics Inc. is recalling 37,554 units of epoc BGEM BUN Test Cards [25pk] because they may produce sodium test results that are lower than the patient's actual levels. The company has observed an average error (bias) of -4.4 mmol/L, with a maximum observed error of -14 mmol/L. While other test measurements on the cards are performing correctly, these inaccurate sodium readings could lead to incorrect medical diagnoses or treatment decisions.
Inaccurate sodium measurements can lead to improper patient management or delayed treatment for electrolyte imbalances. Because quality control (QC) testing may not always detect this specific issue, clinicians might rely on incorrect data without realizing the equipment is malfunctioning.
Quantity: 37,554 units.
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.
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Sources: FDA iRES · Raw API Response
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