BD Affirm™ VPIII Microbial Identification Test 446252Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00382904462529), received between May 14, 2018 and Sep 19, 2025 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE OF BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A FALSE POSITIVE GARDNERELLA VAGINALIS PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099947 ↗
• MalfunctionMay 8, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING USE OF THE BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, AN UNSPECIFIED NUMBER OF PATIENT SAMPLES WERE EITHER CANDIDA SP. OR GARDNERELLA FALSE POSITIVE. CUSTOMER MAY PERFORM A WET PREP TO CONFIRM PRESENCE OF YEAST, AND MAY SEND SPECIMENS FOR PAP SMEARS OR "NEXT GEN" TESTING. CUSTOMER DID NOT KNOW IF CONFIRMATORY TESTING WAS DONE FOR ALL QUESTIONABLE RESULTS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19269135 ↗
• MalfunctionApr 29, 2024False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING THE BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WERE AN UNSPECIFIED NUMBER OF FALSE NEGATIVE CANDIDA SP. OR GARDNERELLA RESULTS ON PATIENT SAMPLES. CUSTOMER MAY SEND SPECIMENS FOR PAP OR NEXT GEN TESTING OR PERFORM A WET PREP TO CONFIRM PRESENCE OF YEAST IF CANDIDA RESULT WAS NEGATIVE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202727 ↗
• MalfunctionApr 26, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A PATIENT PREVIOUSLY TESTED POSITIVE FOR GARDNERELLA VAGINALIS, TREATED, AND CONTINUED TO TEST POSITIVE POST TREATMENT. THE PROVIDER QUESTIONED THE LENGTH OF TIME THE PATIENT CONTINUED TO TEST POSITIVE, AND SUSPECTED THE RESULT WAS ERRONEOUS. NO PATIENT IMPACT WAS REPORTED. REPORT 2 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197590 ↗
• InjuryApr 26, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A PATIENT TESTED POSITIVE FOR GARDNERELLA VAGINALIS. THE PROVIDER PRESCRIBED MEDICATION AND QUESTIONED THE RESULT AFTER THE PATIENT CONTINUED TO TEST POSITIVE FOR GARDNERELLA POST TREATMENT. REPORT 1 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197418 ↗
• MalfunctionApr 26, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A PATIENT PREVIOUSLY TESTED POSITIVE FOR GARDNERELLA VAGINALIS, TREATED, AND CONTINUED TO TEST POSITIVE POST TREATMENT. THE PROVIDER QUESTIONED THE LENGTH OF TIME THE PATIENT CONTINUED TO TEST POSITIVE, AND SUSPECTED THE RESULT WAS ERRONEOUS. NO PATIENT IMPACT WAS REPORTED. REPORT 3 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197416 ↗
• MalfunctionApr 26, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A PATIENT PREVIOUSLY TESTED POSITIVE FOR GARDNERELLA VAGINALIS, TREATED, AND CONTINUED TO TEST POSITIVE POST TREATMENT. THE PROVIDER QUESTIONED THE LENGTH OF TIME THE PATIENT CONTINUED TO TEST POSITIVE, AND SUSPECTED THE RESULT WAS ERRONEOUS. NO PATIENT IMPACT WAS REPORTED. REPORT 5 OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197415 ↗
• MalfunctionApr 26, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, A PATIENT PREVIOUSLY TESTED POSITIVE FOR GARDNERELLA VAGINALIS, TREATED, AND CONTINUED TO TEST POSITIVE POST TREATMENT. THE PROVIDER QUESTIONED THE LENGTH OF TIME THE PATIENT CONTINUED TO TEST POSITIVE, AND SUSPECTED THE RESULT WAS ERRONEOUS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197414 ↗
• MalfunctionAug 14, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, THERE WAS ONE FALSE POSITIVE OF A PATIENT RESULT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS ONE PATIENT POSITIVE FOR ALL TARGETS WHILE USING CAT 446252 LOT 3102251."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547455 ↗
• MalfunctionJun 26, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING USE WITH THE BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER WAS USING 446257 KITS FOR 9 YEARS, AND ABOUT A YEAR AGO, THEY SWITCHED TO 446252; CUSTOMER REPORTS AN INCREASED BACKGROUND COLOR FOR GARDNERELLA THAT MAY BE AFFECTING OVERALL RESULT; THE VERY LOW, LIGHT BLUE G. VAGINALIS SHOWS ON ALL 3 INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204937 ↗
• MalfunctionDec 29, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST THAT THERE WAS FASLE POSITIVES. IT WAS REPORTED THAT 7 LOTS WERE INVOLVED. SEE H.10. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFFIRM 446252 - KIT AFFIRM VPIII CLINICAL POSITIVE RATE INCREASE FOR TRICHOMONAS ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16073602 ↗
• InjuryDec 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST REAGENT WAS INJECTED INTO FINGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? YES. CUSTOMER STATES THE EMPLOYEE INADVERTENTLY INJECTED A TINY AMOUNT OF AFFIRM VPIII REAGENT INTO HER FINGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15972584 ↗
• MalfunctionAug 18, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY THE CUSTOMER THAT - ISSUE WITH QC. BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST WHICH ALSO AFFECTED THREE PATIENT SAMPLES. REPEAT TESTING WAS PERFORMED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE A HALF OF BOX THAT WE ARE THROWING AND AFFECTED 3 PATIENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255046 ↗
• MalfunctionJun 16, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST HAD ONE PATIENT SAMPLE POSITIVE FOR GARDNERELLA AND NEGATIVE FOR CANDIDA, WHILE ON CULTURE GARDNERELLA WAS NEGATIVE, AND THERE WAS A LOW POSITIVE FOR CANDIDA. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS A PATIENT SAMPLE BEING POS FOR GV AND NEG FOR CANDIDA, YET ON CULTURE GARDNERELLA WAS NEG, AND THERE WAS A LOW POS FOR CANDIDA. CUSTOMER CONSIDERS AFFIRM RESULTS BEING "FALSE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14715706 ↗
• MalfunctionSep 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING KIT AFFIRM VPIII CLINICAL, A DISCREPANT RESULT FOR TRICHOMONAS WAS OBTAINED BY THE LAB. AS THE PHYSICIAN QUESTIONED THE RESULT, A SECOND SAMPLE WAS OBTAINED AND TESTED, WHERE ONLY THE G VAGINALIS RESULT WAS POSITIVE. THE RESULTS ARE CURRENTLY PENDING INVESTIGATION, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTING ONE DISCREPANT RESULT (TRICHOMONAS) ON THE AFFIRM VPIII ASSAY CATALOG# 446252, LOT# 1120762. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: INITIAL RESULT ON (B)(6) 2021: THE PATIENT SAMPLE WAS POSITIVE FOR TRICHOMONAS AND G VAGINALIS. THE PHYSICIAN QUESTIONED THE RESULT AND A REPEAT SAMPLE WAS COLLECTED ON (B)(6) 2021. THE PATIENT WAS POSITIVE FOR G VAGINALIS ONLY AND NOT TRICHOMONAS ON THE SECOND SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS ON ANY TYPE OF ANTIMICROBIAL THERAPY. CONFIRMED THAT LAB ROOM TEMPERATURE IS ON THE LOW SIDE (TYPICALLY 21 DEGREES). INTERNAL QC BEADS SATISFACTORY ON THE PACS. EXTERNAL QC HAS BEEN SATISFACTORY. LYSIS BLOCK TEMPERATURE IS WITHIN RANGE. LAB HAS BEEN PASSING THEIR PROFICIENCY TESTING NEXT STEPS (IF NECESSARY): INVESTIGATE. RESOLUTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422194 ↗
• MalfunctionMay 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING KIT AFFIRM VPIII CLINICAL 6 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: AFF 446252 GARDNERELLA POS RATE INCREASE. ALL PT PASSED, CUSTOMER REPORTS 5% INCREASE IN POSITIVITY RATE FOR GARDNERELLA ONLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877638 ↗
• MalfunctionApr 6, 2021False Positive Result; False Positive Result

  IT WAS REPORTED WHILE TESTING WITH BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST FALSE POSITIVE RESULTS FOR TRICHOMONAS WERE OBTAINED ON 3 SYMPTOMATIC PATIENTS. THERE WAS NO REPORT IF REPEAT OR CONFIRMATORY TESTING WAS PERFORMED. RESULTS WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS AN INCREASE IN POSITIVES FOR TRICHOMONAS. THREE POSITIVE TRICHOMONAS SAMPLES IN ONE DAY. THIS IS ATYPICAL FOR THE LAB. CONFIRMED TESTING AREA TEMPERATURE IS TYPICALLY 23 DEGREES, LYSIS BLOCK TEMPERATURE 86 DEGREES. REVIEWED WORKFLOW-TEST PERFORMED ACCORDING TO PI RECOMMENDATIONS. EXTERNAL QC WAS SATISFACTORY. ISSUE SEEMED TO OCCUR WITH THE OPENING OF NEW KIT/LOT#. GARDNERELLA WAS ALSO POSITIVE ON EACH OF THE PAC CARDS ALONG WITH TEH TRICHOMONAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11621155 ↗
• MalfunctionMar 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST A HIGH RATE OF FALSE POSITIVE RESULTS WAS OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547831 ↗
• InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECHNICIAN RECEIVED A CUT FROM A BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST WHILE ATTEMPTING TO FILTER THE PATIENT'S SAMPLE. EXPOSURE TO PATIENT SAMPLE THROUGH CUT. TECHNICIAN RECEIVED FIRST AID. NO OTHER MEDICAL INTERVENTION REPORTED.

  Patient problems: Exposure to Body Fluids; Laceration(s)

  MAUDE report 7511101 ↗