Product Wiki · Recalls · Health Canada — Medical Devices

ADVIA Centaur and ADVIA Centaur CP System — recall 60748

Health Canada — Medical Devices · Canada · 2018-03-19 · Type III

As described by Health Canada — Medical Devices: ADVIA Centaur and ADVIA Centaur CP System - Creatine Kinase-MB (CKMB) Assay (2018-02-28)

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Agency
Health Canada — Medical Devices
Recall identifier
60748
Date of alert
2018-03-19
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens' complaint investigation has confirmed that the calibration flag "Invalid, Exceeded defined ranges" may be triggered due to the slope value exceeding the acceptable range. The resulting invalid calibration prevents customers from generating CKMB results. When valid calibrations and in range Quality Control (QC) results are obtained, patient results are valid and acceptable for reporting. When an invalid calibration is received, QC and patient testing cannot be performed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-and-advia-centau

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