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Health Canada Medical devices

VITROS Chemistry Product System-Ca Slides (Calcium)

Issued July 24, 2025
Issue
Generations (Gens) 67 and above of VITROS CA slides may experience an increased occurrence of condition code th4-63j during calibration, on VITROS XT 3400 and VITROS XT 7600 systems. Condition code th4-63j is generated when the reflectometer detects image variations which exceed an assay parameter defined on the assay data disk (add). If condition code th4-63j is generated during calibration, the calibration may fail. Recall start date: July 14, 2025
Hazard description
Performance
Product
Product name
VITROS Chemistry Product System-Ca Slides (Calcium)
Reference
ID
RA-77764