Siemens Healthineers has issued a recall for 9 units of the RAPIDPoint 500e Blood Gas System running software version 5.3 due to a software error that misidentifies patient samples. When using 'capillary mode,' the system incorrectly labels these samples as 'arterial' when they are sent to the Laboratory Information System (LIS). This error occurs even though the sample is correctly identified as capillary on the device's own screen and printouts. Because capillary and arterial blood have different normal ranges, this labeling error could lead to incorrect medical diagnoses or treatment decisions.
The software error causes capillary samples to be compared against arterial reference ranges in a hospital's central computer system. This mismatch can cause results to be flagged incorrectly, potentially leading healthcare providers to make harmful management decisions based on inaccurate data interpretation.
Information and Software Correction
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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