COBAS® PCR MEDIA UNI SWAB SAMPLE KIT

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. AN OFF-LABEL SAMPLE COLLECTION WAS PERFORMED. PER THE OPERATOR'S MANUAL, OROPHARYNGEAL SWAB COLLECTIONS ARE INTENDED TO BE PERFORMED BY A CLINICIAN. IT IS POSSIBLE THAT THE PATIENT ACCIDENTALLY BROKE THE SWAB AT THE SCORELINE DURING COLLECTION.

Description of Event or Problem

A CUSTOMER ALLEGED THAT A SWAB, WHICH IS PACKAGED IN THE COBAS® PCR MEDIA UNI SWAB SAMPLE KIT, BROKE DURING SAMPLE COLLECTION. THE PATIENT WAS ALLEGEDLY COLLECTING AN OROPHARYNGEAL SWAB WHEN THE SWAB BROKE DURING SELF-COLLECTION. IT IS UNCLEAR AT WHAT POINT IN THE COLLECTION PROCESS THE SWAB BROKE AND IF ANY TREATMENT WAS ADMINISTERED. NO FURTHER HARM WAS REPORTED.