BINX IO CT/NG ASSAY

Description of Event or Problem

THE BINX IO CT/NG CARTRIDGE, WHEN TESTED USING THE BINX IO INSTRUMENT, IS A FULLY AUTOMATED, RAPID, QUALITATIVE TEST INTENDED FOR USE IN POINT-OF-CARE OR CLINICAL LABORATORY SETTINGS FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS (CT) AND NEISSERIA GONORRHOEAE (NG) DNA BY POLYMERASE CHAIN REACTION. LOT 00210869309 OF THE BINX IO CT/NG CARTRIDGES FAILED ITS FINISHED PRODUCT QUALITY CONTROL (QC) TESTING. LOT 00210869309 WAS QUARANTINED ON 13 JULY 2022 AND NO DEVICES FROM THIS LOT WERE TO BE DISTRIBUTED TO CUSTOMERS. LOT 00210869309 WAS INTENDED FOR INTERNAL USE ONLY BY BINX HEALTH FIELD SERVICE EMPLOYEES FOR PERFORMING TEST ASSESSMENTS. A PROCESSING ERROR BY A THIRD-PARTY LOGISTICS PROVIDER MEANT THAT ONE BOX OF LOT 00210869309 PRODUCT WAS INADVERTENTLY ALLOCATED TO A CUSTOMER ORDER AND SHIPPED TO A SINGLE SITE ON 09 FEBRUARY 2023. ONE BOX EQUALS FIFTY CT/NG CARTRIDGES. THE PROCESSING ERROR WAS IDENTIFIED DURING AN INTERNAL INVENTORY RECONCILIATION ON 14 MARCH 2023. INFORMATION REGARDING PATIENT OUTCOMES BASED ON PATIENT SAMPLES RUN USING THE CT/NG CARTRIDGES FROM LOT 00210869309 HAS NOT BEEN SHARED WITH BINX HEALTH AT THIS TIME.