Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Enzyme Calibrator's (2016-05-13) — recall 55485

Health Canada — Medical Devices · Canada · 2016-05-30 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55485
Date of alert
2016-05-30
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 received complaints of positive shift of patient and QC results when the ALTI assay is calibrated with specific lots of Dimension Enzyme II Calibrator. Internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibration lots. The shift began with lot 4MDO47.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-enzyme-calibrator-s-

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