During internal testing, QuidelOrtho™ identified that microwell assay results have the potential to be reported without the reagent expired (re) result code, even when the signal reagent (sr) pack is past the expiry date. This can occur when an sr pack exceeds the on-board expiry and/or the shelf expiration date. This issue can affect any microwell assay regardless of whether or not the system is configured to use expired reagents. Recall start date: December 24, 2024
RecallTracker