BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit 256045Recalls & reported problems
Becton, Dickinson And Company · Kit Flu A+B 30 Test Physician Veritor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Veritor is a rapid test system used to check patients quickly for influenza A and B. Its 253 reports mostly describe incorrect or unclear test results, including suspected wrong positive results and readings where the test line did not appear in the right spot, and some describe an RSV test cartridge packaged in a flu kit. The reports include 16 injuries and no deaths. Reports fell from 117 in the previous 12 months to 8 in the most recent 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 251
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 251 adverse event reports that list this exact device (DI 00382902560456), received between Mar 13, 2018 and Feb 23, 2026 — classified as 16 injuries, 235 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (139 reports).
3 other recalls cover devices cleared under the same FDA submission (K112277, K132259, K132692, K151291, K152870, K160161, K180438, K223016, K232434); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings139
- False Positive Result99
- False Negative Result7
- Device Contamination with Chemical or Other Material4
- Device Markings/Labelling Problem2
- Detachment of Device or Device Component1
- Expiration Date Error1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions248
- No Consequences Or Impact To Patient8
- Chemical Exposure1
- No Code Available1
Recent adverse event reports
The 25 most recent of 251 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, ONE (1) FLU A NEGATIVE RESULT WAS OBTAINED FROM A VERITOR ANALYZER. HOWEVER, THE USER VISUALLY READ THE TEST CARTRIDGE AND QUESTIONED THE NEGATIVE RESULT. THE TESTING WAS REPEATED ON THE VERITOR ANALYZER USING LEFTOVER EXTRACTION REAGENT FROM THE INITIAL SAMPLE COLLECTION AND A NEW TEST CARTRIDGE, WHICH PROVIDED A FLU A POSITIVE RESULT. NO CONFIRMATORY TESTING WAS REPORTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24421802 ↗MalfunctionFeb 10, 2026Device Markings/Labelling Problem
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE CONTENTS INCLUDED ONE (1) RSV CARTRIDGE PACKAGED INSIDE A FOIL WRAPPER LABELED AS A FLU A+B CLIA-WAIVED DEVICE. THE RSV CARTRIDGE WAS USED FOR PATIENT TESTING; HOWEVER, THE USER NOTICED THE TEST CARTRIDGE/PACKAGING LABEL DISCREPANCY AND A NEW PATIENT SAMPLE WAS COLLECTED TO PERFORM THE CORRECT TESTING ORDERED BY THE PROVIDER. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305083 ↗MalfunctionFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE CUSTOMER OBTAINED ONE (1) ERRONEOUS PATIENT RESULT ON A REPEATED (THIRD TIME) SPECIMEN. PER THE CUSTOMER, A POSITIVE RESULT WAS EXPECTED AS THE PATIENT WAS SYMPTOMATIC; HOWEVER, THE RESULT WAS CONSIDERED INCONCLUSIVE AS THE TESTING LINE WAS NOT IN THE CORRECT SPOT. THERE WAS NO REPORT OF PERFORMING CONFIRMATORY TESTING. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THE CUSTOMER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B AND NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER AFTER SEVERAL FOLLOW UP ATTEMPTS BY BD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298570 ↗MalfunctionFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE CUSTOMER OBTAINED ONE (1) ERRONEOUS PATIENT RESULT ON A RECOLLECTED SPECIMEN. PER THE CUSTOMER, A POSITIVE RESULT WAS EXPECTED AS THE PATIENT WAS SYMPTOMATIC; HOWEVER, THE RESULT WAS CONSIDERED INCONCLUSIVE AS THE TESTING LINE WAS NOT IN THE CORRECT SPOT. PATIENT RETESTING OCCURRED A THIRD TIME. THERE WAS NO REPORT OF PERFORMING CONFIRMATORY TESTING. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THE CUSTOMER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B AND NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER AFTER SEVERAL FOLLOW UP ATTEMPTS BY BD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298566 ↗MalfunctionFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE CUSTOMER OBTAINED ONE (1) ERRONEOUS PATIENT RESULT. PER THE CUSTOMER, A POSITIVE RESULT WAS EXPECTED AS THE PATIENT WAS SYMPTOMATIC; HOWEVER, THE RESULT WAS CONSIDERED INCONCLUSIVE AS THE TESTING LINE WAS NOT IN THE CORRECT SPOT. SAMPLE RECOLLECTION AND RETESTING OCCURRED. THERE WAS NO REPORT OF PERFORMING CONFIRMATORY TESTING. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THE CUSTOMER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B AND NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER AFTER SEVERAL FOLLOW UP ATTEMPTS BY BD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24298531 ↗MalfunctionNov 18, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS WERE OBTAINED. IN ADDITION, IT WAS NOTED THAT QC FAILED. THE CUSTOMER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585508 ↗MalfunctionOct 27, 2025False Positive Result; False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS RECEIVED FROM THE CUSTOMER AFTER SEVERAL FOLLOW UP ATTEMPTS BY BD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393980 ↗MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WAS A FLU A RESULT THAT WAS DISCREPANT WHEN COMPARED TO THE BIOFIRE RESPIRATOY PANEL FLU A RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961319 ↗MalfunctionSep 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WAS A FLU A RESULT THAT WAS DISCREPANT WHEN COMPARED TO THE BIOFIRE RESPIRATOY PANEL FLU A RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961313 ↗MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WAS A FLU A RESULT THAT WAS DISCREPANT WHEN COMPARED TO THE BIOFIRE RESPIRATOY PANEL FLU A RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951800 ↗MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WAS A FLU A RESULT THAT WAS DISCREPANT WHEN COMPARED TO THE BIOFIRE RESPIRATORY PANEL FLU A RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951798 ↗MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WAS A FLU A RESULT THAT WAS DISCREPANT WHEN COMPARED TO THE BIOFIRE RESPIRATORY PANEL FLU A RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951797 ↗MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WAS A FLU A RESULT THAT WAS DISCREPANT WHEN COMPARED TO THE BIOFIRE RESPIRATOY PANEL FLU A RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951796 ↗MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WAS A FLU A RESULT THAT WAS DISCREPANT WHEN COMPARED TO THE BIOFIRE RESPIRATOY PANEL FLU A RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951795 ↗MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THERE WAS A FLU A RESULT THAT WAS DISCREPANT WHEN COMPARED TO THE BIOFIRE RESPIRATORY PANEL FLU A RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951792 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950024 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950022 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950021 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950018 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950013 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950011 ↗MalfunctionSep 3, 2025False Positive Result; False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22949782 ↗MalfunctionSep 2, 2025False Positive Result; False Positive Result
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939146 ↗MalfunctionAug 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, CONTAMINATION ON THE TEST DEVICE LED TO A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894421 ↗MalfunctionAug 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, CONTAMINATION ON THE TEST DEVICE LED TO A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894416 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K112277, K132259, K132692, K151291, K152870, K160161, K180438, K223016, K232434. One submission often covers many models, so check the product and lot details in each record.
- Z-0630-2022 · Jan 5, 2022 · Open, ClassifiedBD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
- Z-1313-2019 · Apr 3, 2019 · TerminatedBD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
- Z-1314-2019 · Apr 3, 2019 · TerminatedBD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
Other Devices detecting influenza A, B, and C virus antigens devices
- ID NOW Influenza A & B 2 427-000Alere Scarborough, Inc. · Devices Detecting Influenza A, B, And C Virus Antigens3 recalls2 reports
- BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit 256041Becton, Dickinson And Company · Devices detecting influenza A, B, and C virus antigens82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page