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Dimension Vista System - Ca15-3 Flex Reagent Cartridge — recall 64403

Health Canada — Medical Devices · Canada · 2022-07-25 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64403
Date of alert
2022-07-25
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthineers has received customer complaints for negative patient bias with the Dimension Vista Loci Ca15-3 assay. Siemens has confirmed the Dimension Vista Loci Ca15-3 lots show a negative bias with patient samples. The mean patient sample bias for the lots listed range from -26% to -33%. Patient bias is consistent across the analytical measurement range (AMR). The highest bias observed on a patient sample (56 u/ml) was - 47%. Quality control does not detect this issue Recall start date: July 26, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-system-ca15-3-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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