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

Description of Event or Problem

IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THE CUSTOMER USED OFF LABEL PANBIO¿ COVID-19 AG TEST SWABS FOR SAMPLE COLLECTION, WHICH RESULTED IN FALSE POSITIVE RESULTS. UPON CONFIRMATORY TESTING USING PCR, THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

Additional Manufacturer Narrative

G5. ADDITIONAL 510K: K132259, K132692, K151291, K152870, K160161. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVES WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 3312497. THE CUSTOMER REPORTED THAT THEY RECEIVED DUAL FLU A AND FLU B POSITIVE RESULTS AND FLU B FALSE POSITIVE RESULTS. 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 RETURN SAMPLES WERE RECEIVED; THEREFORE, NO RETURN SAMPLE ANALYSIS COULD BE PERFORMED. THE RETURNED PHOTOGRAPH ONLY PROVIDED THE KIT BATCH INFORMATION. HOWEVER, A SUPPLEMENTAL TESTING WAS PERFORMED AND INDICATED THAT THE REPORTED ISSUE MAY OCCUR WHEN USING THE SWAB USED IN THE PANBIO¿ COVID-19 AG TEST. THE REPORTED ISSUE WAS CONFIRMED BASED ON THE SUPPLEMENTAL TEST. THE ROOT CAUSE COULD NOT BE DETERMINED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.