Product Wiki · Recalls · Health Canada — Medical Devices

Optilite Beta-2-microglobulin Urine Kit (2018-03-09) — recall 60795

Health Canada — Medical Devices · Canada · 2018-04-03 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
60795
Date of alert
2018-04-03
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Following an external complaint, investigations were reviewed on the 26/02/2018 and concluded the antigen excess protection of the assay at the initial dilution is only up to 18.4 mg/L (doc. 1 IFU). This does not meet the antigen excess protection (760 mg/L) stated in the IFU.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/optilite-beta-2-microglobulin-

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