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Health Canada Medical devices

VITROS® Chemistry Products System - LAC Slides (Lactate)

Issued August 14, 2025
Issue
QuidelOrtho investigated customer complaints related to the inability to successfully calibrate VITROS® LAC slides on VITROS® XT 3400 systems and VITROS® XT 7600 systems. To resolve this issue, QuidelOrtho has adjusted the assay parameter used by the reflectometer to process VITROS® LAC slides. This parameter adjustment will be implemented beginning in add DRV 6339 (and above). QuidelOrtho advises affected customers to load add DRV 6339 (or above) upon receipt. Recall start date: August 5, 2025
Hazard description
Performance
Product
Product name
VITROS® Chemistry Products System - LAC Slides (Lactate)
Reference
ID
RA-77908