Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component

It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.

On May 6, 2025, URGENT PRODUCT CORRECTION NOTIFICATION letters to customers. REQUIRED ACTION " Do not report Bordetella parapertussis (BPP) positive results when testing with the affected lot numbers. " Use the Solana Bordetella Complete Assay only for reporting Bordetella pertussis (BP) results and negative Bordetella parapertussis (BPP) results only when using the affected lots, as they are not affected. " Review the content of this communication with your Medical Director and retain this letter for your laboratory. " Complete the enclosed Confirmation of Receipt form no later than May 14, 2025. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-874-1517 or [email protected].