VITROS® 4600, 5600 and 7600 Systems

Issue

The VITROS® system software is designed to apply a "reagent expired" (re) code to results if the 'use expired reagents' option has been enabled, and an expired reagent is used. if 'use expired reagents' has not been enabled, the VITROS® system software is expected to report a "no result" and apply an "insufficient inventory (ii)" code when attempting to process samples using expired reagents, including diluents. QuidelOrtho received a customer complaint stating that their VITROS® system had applied an re code to results despite the 'use expired reagents' option not enabled on their VITROS® system. QuidelOrtho investigated the complaint and determined that a software anomaly exists in the VITROS® system software, affecting all available versions. Despite the 'use expired reagents' option not enabled, if a VITROS® diluent pack lot is manually loaded on VITROS® 4600, 5600, and XT 7600 systems with the shelf expiration date left blank, the VITROS® system will flag the pack as expired but report results, applying an re code to the results. Please note that the anomaly will allow the VITROS® system to report results using VITROS® diluent packs which have not reached the shelf expiration date and expired VITROS® diluent packs (as printed on the product labeling), if the VITROS® diluent pack was manually loaded with the shelf expiration date left blank. Recall start date: May 22, 2025