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ADVIA Centaur and ADVIA Centaur CP System — recall 58253

Health Canada — Medical Devices · Canada · 2018-08-17 · Type III

As described by Health Canada — Medical Devices: ADVIA Centaur and ADVIA Centaur CP System - Creatine Kinase-MB (CKMB) Assay (2018-07-27)

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Agency
Health Canada — Medical Devices
Recall identifier
58253
Date of alert
2018-08-17
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthcare Diagnostics has identified a bias with ADVIA Centaur CKMB Calibrator Kit Lots ending in 64 (ck64) when compared to internal standards and previously released ADVIA Centaur CKMB Calibrator Kit Lots ending in 63 (ck63) on the ADVIA Centaur/XP/XPT and ADVIA Centaur CP systems. Alignment to the internal standardization is restored with the release of ADVIA Centaur CKMB Calibrator Kit Lots ending in 68 (ck68). Customers may observe a shift in Quality Control (QC) material, Master Curve Material (MCM) and patient results when transitioning from ADVIA Centaur CKMB Calibrator Kit Lots ending in 64. Siemens has also identified the potential for out of range ADVIA Centaur CKMB Master Curve Material results when using the lot 35061on the ADVIA Centaur/XP/XPT and ADVIA Centaur CP systems.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-and-advia-centau

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