Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Vista V-LYTE Integrated Multisensor Na+ / K+ / Cl- — recall 44384

Health Canada — Medical Devices · Canada · 2017-01-12 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
44384
Date of alert
2017-01-12
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Siemens Healthcare Diagnostics has confirmed a low bias for dimension Vista V-Lyte integrated Multisensor Urine Potassium when compared to the dimension QuikLyte Integrated Multisensor, which is the predicate device used in the method comparison section of the v-lyte instructions for use (IFU). Please note, serum/plasma potassium results are not affected by this issue as there are separate parameters for serum/plasma potassium.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-v-lyte-integra

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