Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Vista System (2015-05-20) — recall 53576

Health Canada — Medical Devices · Canada · 2015-06-15 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
53576
Date of alert
2015-06-15
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Issue # 1: Manufacturer received complaints for samples not processing without notification on the Dimension Vista 500 or Dimension Vista 1500 using software versions 3.6.1 in most cases, user action of pause / cancel pause is effective in restoring lane operation and the samples will resume processing. However in a few cases it was necessary to shutdown the instrument software and restart to recover. In all cases the affected samples are resubmitted and run successfully. Issue # 2: Manufacturer received complaints for unexpected less than lower assay range (< l) or results that were flagged with assay errors on Dimension Vista 1500 systems using software versions 3.6.1. Result data and the physical evidence from flexes suggested that a reagent server lost synchronization and the software was unaware of the problem.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-system-2015-05

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