COBAS® SARS-COV-2 & INFLUENZA A/B

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS® LIAT® ANALYZER IS (B)(6). THE AFFECTED RUN DATA COULD NOT PROVIDED FOR REVIEW AND ANALYSIS. THE REAGENT INVESTIGATION DID NOT IDENTIFY A SYSTEMIC PRODUCT PROBLEM. THE EXACT ROOT CAUSE OF THE ISSUE REMAINS UNKNOWN.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE SARS-COV-2 RESULT FOR A PATIENT SAMPLE USING COBAS® SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR SARS-COV-2 (NEGATIVE FOR INFLUENZA A/B). THE SAME SAMPLE WAS REPEATED ON A COMPETITOR ASSAY (GENEXPERT) AND WAS NEGATIVE. THE REPEAT RESULT WAS DEEMED CORRECT, AND THE PATIENT'S RESULT WAS REPORTED AS NEGATIVE.