Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Vista System - Enzyme Calibrator (2014-01-20) — recall 50683

Health Canada — Medical Devices · Canada · 2014-02-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
50683
Date of alert
2014-02-11
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: There have been reports of quality control (QC) shifts with pseudocholinesterase (PCHE) and imprecision during PCHE calibration with Dimension Vista enzyme 1 calibrator (ENZ 1 cal) lots 3FD034 and 3HD012. Investigation by Siemens confirms a loss of PCHE activity in the affected lots of enzyme 1 calibrator, causing an elevation of qc by as much as 80% and in some instances, imprecision of replicates during calibration.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-vista-system-enzyme-

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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