BD Veritor™ System For Rapid Detection of RSV - CLIA waived kit 256038Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382902560388), received between Jul 2, 2021 and Mar 5, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV CLIA-WAIVED KIT, A RSV POSITIVE RESULT FOR ONE (1) PATIENT WAS OBTAINED FROM A VERITOR ANALYZER. THE USER VISUALLY OBSERVED AN EXTRA LINE ON THE TEST CARTRIDGE AND QUESTIONED THE ANALYZER RESULT. THE PATIENT WAS RECOLLECTED AND A NEW SAMPLE WAS PROCESSED ON A DIFFERENT VERITOR ANALYZER WHICH PROVIDED A RSV NEGATIVE RESULT. THE USER WAS UNSURE WHICH RSV RESULT WAS CORRECT BASED ON THE EXTRA LINE OBSERVED ON THE TEST CARTRIDGE. IT IS NOTED THE PATIENT RESULT THE CUSTOMER WAS EXPECTING IS NOT KNOWN AND THERE WAS NO REPORT OF CONFIRMATORY TESTING. IT SHOULD ALSO BE NOTED THE ACTION OF VISUALLY READING A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WAS NO HEALTH IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524739 ↗
• MalfunctionJun 26, 2025False Positive Result; False Positive Result

  REPORT 2 OF 2. IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - CLIA WAIVED KIT, ONE (1) FALSE POSITIVE RSV PATIENT SAMPLE WAS OBTAINED. IT WAS NOTED THE POSITIVE RSV RESULT DID NOT COINCIDE WITH THE PATIENT'S MEDICAL HISTORY. CONFIRMATORY TESTING WAS PERFORMED USING PCR AND A RSV NEGATIVE RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337542 ↗
• MalfunctionJun 26, 2025False Positive Result; False Positive Result

  REPORT 1 OF 2. IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - CLIA WAIVED KIT, ONE (1) FALSE POSITIVE RSV PATIENT SAMPLE WAS OBTAINED. IT WAS NOTED THE POSITIVE RSV RESULT DID NOT COINCIDE WITH THE PATIENT'S MEDICAL HISTORY. CONFIRMATORY TESTING WAS PERFORMED USING PCR AND AN RSV NEGATIVE RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337536 ↗
• MalfunctionDec 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE KIT RSV 30 TEST PHYSICIAN VERITOR THE USER VISUALLY INSPECTS THE CARTRIDGE AND QUESTIONS THE RESULT WHEN THREE LINES INSTEAD OF TWO WAS OBSERVED. THE READER PROVIDED A NEGATIVE RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250857 ↗
• MalfunctionAug 11, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT KIT RSV 30 TEST PHYSICIAN VERITOR DISCREPANT RESULTS COMPARED TO PCR RESULTS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANCY IN THE RESULTS OF RAPID RESPIRATORY VIRUS TESTS (RSV AND FLU) VERSUS THE PCR RESULTS PERFORMED BY BD MAX. RAPID TESTS WERE PERFORMED ON NASOPHARYNGEAL SWABS. FOR VSR, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 1294669 AND EXPIRATION DATE: 09-20-2024. FOR FLU, THE BD VERITOR SYSTEM CLIA KIT WAS USED, LOT: 2292271 AND EXPIRATION DATE: 10-12-2025. PCR WAS PERFORMED ON NASOPHARYNGEAL ASPIRATES USING THE BD MAX SARS-COV2/FLU KIT, LOT 2270730 AND EXPIRATION DATE: 05-12/2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17507412 ↗
• MalfunctionJul 8, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING KIT RSV 30 TEST PHYSICIAN VERITOR THE CUSTOMER RECEIVED FALSE POSITIVE RESULTS. A CONFIRMATORY PCR TEST PERFORMED ON THE SAME DAY PRODUCED NEGATIVE RESULTS. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FALSE POSITIVE RSV RESULT ON KIT "256038" LOT # 1294741", "CUSTOMER HAD 1 TEST COME BACK AS POSITIVE ON THE VERITOR BUT IT WAS NEGATIVE WITH CONFIRMATION TEST "PCR". CUSTOMER SAYS THE CONFIRMATION TESTS WERE DONE ON THE SAME DAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958788 ↗
• MalfunctionJun 8, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE TESTING WITH THE KIT RSV 30 TEST PHYSICIAN VERITOR, A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED, AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORT 1 ERRONEOUS RESULT WHEN PERFORMING RSV TEST. ¿ WAS INDIVIDUAL SYMPTOMATIC OR ASYMPTOMATIC? THE PATIENTS HAD CONGESTIONS AND RUNNY NOSES AND AFEBRILES. ¿ HOW WAS IT DETERMINED TO BE DISCREPANT? WE SENT ANOTHER SAMPLES TO THE LAB (PARKWAY LABS) THEY RUN IT FOR TWO DAYS IN THERE SYSTEM AND IT CAME BACK WITH A NEGATIVE RESULT. ¿ COMPARISON TO ANOTHER METHOD? PARKWAY LABS METHOD VS BD VERITOR METHOLOGY AND BOTH USES NASALPHARYNGEAL SWABS TO OBTAIN THE SAMPLES. ¿ WAS THE CARTRIDGE RERUN (RE-READ)? YES, JUST TO MAKE SURE THAT WE HAVE THE SAME RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639503 ↗
• MalfunctionJul 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING 4 KIT RSV 30 TEST PHYSICIAN VERITOR FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. 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: "ONE PATIENTS WAS TOOK SAMPLE 2 TIMES. 1 SAMPLE AS TEST IN 2 CARTRIDGE.. THE 1ST SAMPLES WAS TOOK AND TEST WITH: 1 ST CARTRIDGE ( LOT 0142775) AND LABELLED AS 480871 - L1. RESULTS: 3 LINES ON CARTRIDGE - READER GAVE NEG. AFTER THAT 2ND CARTRIDGE ( LOT 0142775) WAS TRIED IT WAS LABELLED AS 480871 - L2. RESULTS: 3 LINES ON CARTRIDGE - READER GAVE POS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197305 ↗
• MalfunctionJul 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING KIT RSV 30 TEST PHYSICIAN VERITOR FALSE POSITIVE REUSLTS WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ASAN TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " AFTER PROCESSING SAMPLE WAS ADDED IN TO THE BD VERITOR RSV CARTRIDGE. AFTER INCUBATION TIME, 3 LINES WERE APPEARED ON THE CARTRIDGE, AND VERITOR PLUS ANALYSIS GAVE POSITIVE RESULT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111640 ↗