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Vitros Chemistry Products Calibrator Kit 20 — recall 73695

Health Canada — Medical Devices · Canada · 2023-05-19 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
73695
Date of alert
2023-05-19
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: The Vitros Chemistry Products Calibrator Kit 20 is used to calibrate Microtip assays C3, C4, IgM, IgA, IgG, and transferrin. Vitros Calibrator Kit 20 contains five calibrator levels. Although lot 2022 met all initial release criteria, vial to vial variability was subsequently observed during routine internal testing. This prompted an investigation that confirmed that the level 5 calibrator exhibited vial to vial variability which may cause a bias for all six affected assays, although to varying magnitudes. Recall start date: May 9, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-chemistry-products-cali

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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