Product Wiki · Recalls · Health Canada — Medical Devices

CVM Material for Calibration Verification of Blood Gas, Electrolyte… — recall 58153

Health Canada — Medical Devices · Canada · 2018-08-02 · Type III

As described by Health Canada — Medical Devices: CVM Material for Calibration Verification of Blood Gas, Electrolyte, Total Hemoglobin, Bilirubin, and Metabolite Systems (2018-07-16)

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Agency
Health Canada — Medical Devices
Recall identifier
58153
Date of alert
2018-08-02
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthcare Diagnostics has confirmed that the CVM level 1 pCO2 and/or tHb results may recover low within range or lower than expected with the lots 350701 and 350702 of CVM. These lower recoveries may be observed on both the RAPIDPoint and the RAPIDLab Blood Gas Systems. CVM levels 2 through 5 are not affected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cvm-material-calibration-verif

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