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Health Canada Medical devices

Vitros Chemistry Products Calibrator Kit 20

Issued May 19, 2023
Issue
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
Hazard description
Performance
Product
Product name
Vitros Chemistry Products Calibrator Kit 20
Reference
ID
RA-73695