Product Wiki · Recalls · Health Canada — Medical Devices

IDS-ISYS-Wash system (2014-01-24) — recall 51279

Health Canada — Medical Devices · Canada · 2014-03-20 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
51279
Date of alert
2014-03-20
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: The ID's continual quality monitoring program has identified that a very small number of wash solution containers have been manufactured without adding the concentrated solution. The potential hazard associated with the use of the device is an increase in the imprecision and a bias relative to the true concentration of samples measured using the IDS-ISYS assays on board the IDS-ISYS analyser.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ids-isys-wash-system-2014-01-2

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