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

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, ONE (1) FLU A NEGATIVE RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE USER VISUALLY READ THE TEST CARTRIDGE AND QUESTIONED THE NEGATIVE RESULT. THE TESTING WAS REPEATED ON THE VERITOR ANALYZER USING LEFTOVER EXTRACTION REAGENT FROM THE INITIAL SAMPLE COLLECTION AND A NEW TEST CARTRIDGE, WHICH PROVIDED A FLU A POSITIVE RESULT. NO CONFIRMATORY TESTING WAS REPORTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVAL- YES. D9. RETURNED TO MANUFACTURER ON: 13-FEB-2026. H3. DEVICE EVAL BY MANUFACTURER- YES. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 5038539. THE CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS. THEY REPORTED THAT THE FIRST TEST RESULT WAS NEGATIVE FOR FLU A. THEY VISUALLY READ THE CARTRIDGE AND REPEATED THE TEST USING THE REMAINING REAGENT, BUT WITH A NEW TEST CARTRIDGE. THE REPEAT TEST HAD A POSITIVE FLU A RESULT. 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 PHOTOS WERE RECEIVED. RETURN SAMPLES WERE RECEIVED AND TESTED. THE RESULTS WERE PASSING AND ACCEPTABLE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS FOR DISCREPANT RESULTS. IT IS ADVISED THAT VERITOR TESTS ARE NOT MEANT TO BE DETERMINED VISUALLY, AND TO USE THE ANALYZER TO INTERPRET RESULTS. 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, ONE (1) FLU A NEGATIVE RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE USER VISUALLY READ THE TEST CARTRIDGE AND QUESTIONED THE NEGATIVE RESULT. THE TESTING WAS REPEATED ON THE VERITOR ANALYZER USING LEFTOVER EXTRACTION REAGENT FROM THE INITIAL SAMPLE COLLECTION AND A NEW TEST CARTRIDGE, WHICH PROVIDED A FLU A POSITIVE RESULT. NO CONFIRMATORY TESTING WAS REPORTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT.

Additional Manufacturer Narrative

B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.