BD Veritor™ System For Rapid Detection of RSV - Laboratory kit 256042Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382902560425), received between Apr 15, 2021 and Oct 16, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT, THERE WERE MISSING LABELS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT LABELS ARE MISSING AND THEY ARE UNABLE TO DETERMINE LOT #S CUSTOMER CLARIFIED THAT THE ISSUE IS THAT THE PLASTIC BAG IN THE PHOTO IS KIT CONTENTS THAT CAME WITHOUT A BOX, SO THEY ARE UNABLE TO DETERMINE THE LOT # OF THE KIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946858 ↗
• InjuryMay 1, 2023False Positive Result; False Positive Result

  REPORT 1 OF 2. IT WAS REPORTED THAT WHILE USING THE BD VERITOR SYSTEM RSV ASSAYS A FALSE POSITIVE WAS OBTAINED CONFIRMATION WAS DONE BY PCR. PATIENT HOSPITAL STAY WAS EXTENDED, NO TREATMENT INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVIDENCE OF 1 FALSE POSITIVE RESULT IN VERITOR PLUS (RESPIRATORY SYNCYTIAL VIRUS-RSV) COMPARED TO A PCR STUDY CARRIED OUT BY THE CITY'S PUBLIC HEALTH LABORATORY. LOT: 1123929 SECONDARY ANALYSIS BY ANOTHER REFERENCE LABORATORY THROUGH MOLECULAR ANALYSIS (PCR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845430 ↗
• InjuryMay 1, 2023False Negative Result; False Negative Result

  REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING THE BD VERITOR SYSTEM FOR RSV ASSAYS THAT THERE WAS A FALSE NEGATIVE WAS OBTAINED, CONFIRMATION WAS DONE BY PCR. PATIENT HOSPITAL STAY WAS EXTENDED, NO TREATMENT INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RSV (RESPIRATORY SYNCYTIAL VIRUS-RSV) FALSE NEGATIVE SECONDARY ANALYSIS BY ANOTHER REFERENCE LABORATORY THROUGH MOLECULAR ANALYSIS (PCR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845427 ↗
• MalfunctionApr 11, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING WITH BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT FALSE POSITIVE RESULTS WERE OBTAINED. TESTING WAS REPEATED AND RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WE OBSERVE MANY FALSE POSITIVE RESULTS WITH LOT NUMBER 128221 OF BD'S RSV ANTIGEN TEST. WE OBTAIN A LINE AT THE CONTROL AND TEST LINE BUT WITH A WIPE THROUGH. IS READ AS POSITIVE BY READER BUT LOOKS DIFFERENT THAN NORMAL. WHEN WE REPEAT SAMPLE THIS ATYPICAL BINDING IS GONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14077321 ↗
• MalfunctionNov 7, 2021False Positive Result; False Positive Result

  IT WAS REPORTED THAT A FALSE POSITIVE RESULT FOR FLU A AND RSV WAS PRODUCED BY THE BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV. CONFIRMATORY TESTING WAS NOT PERFORMED, AND CLINICIANS WERE NOT NOTIFIED OF THE ERRONEOUS RESULTS. THERE WAS ALSO NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVE RESULT NOT CONFIRMED BY REAL TIME PCR FALSE POSITIVE RESULT FOR A CLINICAL SAMPLE, NASOPHARYNGEAL SWAB IN NACL 0,9% FROM A PATIENT... NOT CONFIRMED BY REAL TIME PCR. VISUAL INSPECTION OF THE VERITOR DEVICE SHOWED A VERY LIGHT LINE WHICH WAS INTERPRETED BY THE VERITOR PLUS ANALYSE AS POSITIVE. THE SAME SAMPLE WAS TESTED FALSE POSITIVE FOR RSV, ALSO NOT CONFIRMED BY REAL TIME PCR. PATIENT WAS SARS-COV 2 NEGATIVE." "NO INCORRECT RESULTS WERE REPORTED. " SAME SAMPLE (FROM THE SAME PATIENT) WAS FALSE POSITIVE FOR FLUA AND RSV. ONLY WHEN A SAMPLE IS POSITIVE FOR BOTH FLUA & RSV , WITH A WEAK LINE, A PCR TEST IS PERFORMED FOR CONFIRMATION. ALSO FOR THIS CASE , THE CLINICAL SYMPTONS WERE NOT CORRELATING WITH A POSITIVE RESULT FOR FLUA AND RSV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760763 ↗
• MalfunctionSep 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCREPANCY ON RESULTS. CUSTOMER IS GETTING DISCREPANCY RESULTS ON RSV 256042 LOT: 9227487 EXP: 3/6/2022"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530516 ↗
• MalfunctionApr 15, 2021Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT WHILE USING KIT RSV 30 TEST HOSPITAL VERITOR INCORRECT LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT TYPOS IN SDS OCCURRED. CUSTOMER PROBLEM: CUSTOMER REPORTS TYPOS IN SDS. CUSTOMER REPORTS TYPO ON SDS WITH REAGENT C BEING LISTED AS REAGENT D. REAGENT C ALSO HAS A WARNINGS LISTED IN PACKAGE INSERT (H302, H402, H412). CUSTOMER REQUESTS CORRECTED SDS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671975 ↗