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ADVIA Chemistry System-Enzymatic Creatinine_2 (ECRE_2) Assay… — recall 63081

Health Canada — Medical Devices · Canada · 2020-01-20 · Type II

As described by Health Canada — Medical Devices: ADVIA Chemistry System-Enzymatic Creatinine_2 (ECRE_2) Assay (2019-12-24)

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Agency
Health Canada — Medical Devices
Recall identifier
63081
Date of alert
2020-01-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthcare Diagnostics has become aware of reports of falsely depressed creatinine results for patients on phenindione therapy when using enzymatic methodology. The root cause was confirmed via testing indicating that ADVIA, Dimension and Dimension Vista Enzymatic Creatinine results are potentially interfered by the Phenindione drug and/or its metabolites. Interference has not been observed with the Jaffe methodology.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-chemistry-system-enzymat

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