Product Wiki · Recalls · Health Canada — Medical Devices

Vitros Chemistry Products Na+ Slides — recall 56094

Health Canada — Medical Devices · Canada · 2017-02-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56094
Date of alert
2017-02-01
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: Ortho Clinical Diagnostics (Ortho) identified the potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ cartridges warmed between 1.5 to 8 hours then placed on the analyzer. Ortho has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-chemistry-products-na-s

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