During our internal testing, QuidelOrtho determined that coating 1291 was incorrectly assigned GEN 88, instead of the intended GEN 83. Product labeling for all lots manufactured from coating 1291 lists the generation as GEN 88, including the product carton, foil wrapper, and cartridge (cart) label. The cart label is scanned by the Vitros® System to determine the GEN of the product. The GEN is associated with specific calibration parameters, which are stored on assay data disks and calibration diskettes and used by Vitros systems to process Vitros slides. Recall Start Date: April 25, 2025
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