Siemens—Calibration Verification Material Used for Calibration with RAPIDLab and RAPIDPoint Blood Gas Systems: pCO2 and/or tHb Results May Be Lower than Expected
July 25, 2018 | Risk Management News
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at firstname.lastname@example.org.
In a July 2018 Customer Notification letter submitted by ECRI Institute member hospitals, Siemens states that the above CVMs may recover low within range or yield lower-than-expected results for partial pressure of carbon dioxide (pCO2) and/or total hemoglobin (tHb) when used with RAPIDPoint and RAPIDLab blood gas systems. Siemens further states that this problem does not pose any health or safety risks to operators or patients. The manufacturer has not confirmed the...