Product Wiki · Recalls · Health Canada — Medical Devices

DIMENSION VISTA SYSTEM - CHEM CALIBRATORS (2016-03-01) — recall 54607

Health Canada — Medical Devices · Canada · 2016-03-11 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
54607
Date of alert
2016-03-11
Country / jurisdiction
Canada
Authority classification
Type III
Notice 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 received complaints of "calibrator insert missing" alerts on Dimension Vista Chemistry 3 Calibrator lot 5md004. Internal investigation has confirmed that the vial barcode label reads KC130 instead of the correct catalog number KC130A. When this mismatch occurs between the vial barcode label and the Instructions For Use (IFU) label, the "calibrator insert missing" error is triggered and displayed on the Dimension Vista instrument screen. There is no risk of erroneous results when this issue occurs as no results are generated.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-system-chem-ca

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