Product Wiki · Recalls · Health Canada — Medical Devices

DIMENSION VISTA SYSTEM - HCYS FLEX REAGENT (2016-05-24) — recall 55378

Health Canada — Medical Devices · Canada · 2016-06-13 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55378
Date of alert
2016-06-13
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 that the Dimension Vista Flex HCYS reagent cartridge catalog # K7044, lot number 15243MA shows a reduced open well stability that does not meet the claimed time frame. As a consequence QC recoveries can be found below the assigned ranges, giving invalid runs that may prompt customers to a new calibration.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-system-hcys-fl

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