BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST
Received Jul 30, 2025 · Event occurred Apr 20, 2024
Report 2647876-2025-00214 · MDR key 22662969
Device
Generic name
Dna Probe, Yeast
Manufacturer
Becton Dickinson Caribe Ltd.Catalog number
446257
Lot number
3347514
Product problems
- False Positive Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: QUALITY INITIATED AN INVESTIGATION ON CUSTOMER COMPLAINT OF AFFIRM GV FALSE POSITIVE RESULTS. BATCH HISTORY RECORD REVIEW WAS PERFORMED ON FINISHED PRODUCT WITH SATISFACTORY RESULTS. IN PROCESS AND QC TESTING WERE WITHIN SPECIFICATIONS. FUNCTIONAL AND SPECIFICITY TESTS WERE PERFORMED ON RETENTION SAMPLES WITH SATISFACTORY RESULTS. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED FOR GV FALSE POSITIVE RESULTS. BD WAS UNABLE TO IDENTIFY A ROOT CAUSE FOR INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483
Description of Event or Problem
IT WAS REPORTED WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS A FALSE POSITIVE RESULT FOR GARDNERELLA VAGINALIS. THERE WAS NO REPORT OF PATIENT IMPACT.