BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES LABELING / PACKAGING ISSUE (MIX OF PRODUCT) WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 4135617. THE CUSTOMER REPORTED THAT THEY RECEIVED 1 BOX OF THE MATERIAL AND ONE OF THE PACKAGED TEST DEVICES WAS FOR RSV INSTEAD OF FLU. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. A PHOTOGRAPH WAS RECEIVED, SHOWING THE TEST DEVICE RECEIVED; IT WAS AN RSV TEST DEVICE WITH A FLU TEST DEVICE PACKAGING. THE REPORTED ISSUE IS THEREFORE CONFIRMED PER THE PHOTO PROVIDED. THE ROOT CAUSE CANNOT BE DETERMINED. INVESTIGATION FOUND THAT THE COMPONENT LOTS WERE MANUFACTURED IN MAY 2024. AN IMPROVED VISION SYSTEM WAS INSTALLED IN JULY 2025. THROUGH ADDITIONAL TESTING, IT WAS CONFIRMED THAT THIS UPDATED VISION SYSTEM IS CAPABLE OF IDENTIFYING MISMATCHED ITEMS AND TRIGGERING ALARMS. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS FOR LABELING / PACKAGING ISSUE (MIX OF PRODUCT). THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE CONTENTS INCLUDED ONE (1) RSV CARTRIDGE PACKAGED INSIDE A FOIL WRAPPER LABELED AS A FLU A+B CLIA-WAIVED DEVICE. THE RSV CARTRIDGE WAS USED FOR PATIENT TESTING; HOWEVER, THE USER NOTICED THE TEST CARTRIDGE/PACKAGING LABEL DISCREPANCY AND A NEW PATIENT SAMPLE WAS COLLECTED TO PERFORM THE CORRECT TESTING ORDERED BY THE PROVIDER. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA/510(K)#: K132259;K132692;K151291;K152870;K160161;K180438;K223016;K232434. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE CONTENTS INCLUDED ONE (1) RSV CARTRIDGE PACKAGED INSIDE A FOIL WRAPPER LABELED AS A FLU A+B CLIA-WAIVED DEVICE. THE RSV CARTRIDGE WAS USED FOR PATIENT TESTING; HOWEVER, THE USER NOTICED THE TEST CARTRIDGE/PACKAGING LABEL DISCREPANCY AND A NEW PATIENT SAMPLE WAS COLLECTED TO PERFORM THE CORRECT TESTING ORDERED BY THE PROVIDER. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.