COBAS® CT/NG FOR USE ON THE COBAS® 5800/6800/8800 SYSTEMS

Additional Manufacturer Narrative

THE COBAS 6800 SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF DISCREPANT RESULTS WITH THE COBAS®CT/NG KIT (480T) FROM THE COBAS 6800 ANALYZER. SAMPLE ID: (B)(6) THE SWAB SAMPLE WAS A POOLED RECTAL/PHARYNGEAL SWAB. (B)(6) 2025: CT NEGATIVE, NG POSITIVE (25.8), IC=29.6. SAMPLE ID: (B)(6) URINE (B)(6) 2025: CT NEGATIVE, NG NEGATIVE, IC=30.1. THE SEQUENCING RESULT WAS NEISSERIA MENINGITIDIS.

Additional Manufacturer Narrative

IT WAS NOTED THAT FOR SAMPLE ID: (B)(6), THE SAMPLE WAS POOLED RECTAL/PHARYNGEAL SWAB IN MWE TRANSWAB MEDIUM. PER PRODUCT LABELING, SPECIMENS MUST BE COLLECTED IN COBAS® PCR MEDIA (ROCHE MOLECULAR SYSTEMS, INC.). FOR SAMPLE ID: (B)(6), URINE (NOT DILUTED IN MEDIA) IS NOT AN APPROVED SAMPLE TYPE. BOTH SAMPLES WERE AN OFF-LABEL USE OF THE PRODUCT. THE ROOT CAUSE WAS DUE TO NEISSERIA GONORRHOEAE OCCASIONALLY EXCHANGING GENETIC MATERIAL WITH COMMENSAL BACTERIA COMMONLY FOUND IN THE NORMAL MICROFLORA OF THE MOUTH AND THROAT. IT IS POSSIBLE THAT THIS EXCHANGE MAY INCLUDE ISOLATED DNA SEQUENCES THAT COULD, ON RARE OCCASIONS, PRODUCE A POSITIVE SIGNAL WITH THIS ASSAY.