BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit 256041Recalls & reported problems
Becton, Dickinson And Company · Kit Flu A+B 30 Test Hospital Veritor · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Veritor rapid flu test kit checks patient samples for influenza A and B. Most of the 82 reports describe the kit returning a positive flu result that repeat testing and molecular tests did not confirm, along with occasional inaccurate readings. There are no deaths and 9 injuries, and no recalls name this device. Reports have risen over the past 12 months, with 13 reports compared with 1 the prior year.
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
- 82
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00382902560418), received between Dec 20, 2019 and Mar 3, 2026 — classified as 9 injuries, 73 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (69 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result69
- Incorrect, Inadequate or Imprecise Result or Readings10
- Break1
- False Negative Result1
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FLU B POSITIVE PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. IT WAS NOTED THE USER IMMEDIATELY RE-INSERTED THE SAME CARTRIDGE BACK INTO A VERITOR ANALYZER AND A FLU B NEGATIVE RESULT WAS OBTAINED. THE PATIENT SAMPLE WAS ALSO TESTED USING MOLECULAR PLATFORMS (LIAT ROCHE AND DIASORIAN), AND EACH PROVIDED A FLU B NEGATIVE RESULT. IT SHOULD BE NOTED THE ACTION OF REINSERTING A USED TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500984 ↗MalfunctionMar 3, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FLU B POSITIVE PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. IT WAS NOTED THE USER IMMEDIATELY RE-INSERTED THE SAME CARTRIDGE BACK INTO A VERITOR ANALYZER AND A FLU B NEGATIVE RESULT WAS OBTAINED. THE PATIENT SAMPLE WAS ALSO TESTED USING MOLECULAR PLATFORMS (LIAT ROCHE AND DIASORIAN), AND EACH PROVIDED A FLU B NEGATIVE RESULT. IT SHOULD BE NOTED THE ACTION OF REINSERTING A USED TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499883 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 10 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429733 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 9 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429731 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 8 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429728 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 4 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429725 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 3 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429724 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 5 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429723 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 6 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429722 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 2 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429720 ↗MalfunctionFeb 24, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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. THIS IS REPORT 7 OF 10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429714 ↗MalfunctionFeb 23, 2026False Positive Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER 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 24421805 ↗MalfunctionFeb 6, 2026False Negative Result
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, AN UNSPECIFIED NUMBER OF FLU A FALSE NEGATIVE RESULTS WERE OBTAINED. IT WAS NOTED THE CUSTOMER WAS EXPECTING FLU A POSITIVE RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283392 ↗MalfunctionMar 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING ONE (1) BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, DISCREPANT FLU RESULTS WERE OBSERVED WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. OTHER NON SPECIFIED TESTS PROVIDED POSITIVE FLU RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514986 ↗MalfunctionJan 11, 2024False Positive Result; False Positive Result
IT IS REPORTED THAT DURING USE OF THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THREE 3 LINES APPEARED ON TEST CARTRIDGE: CONTROL, FLU A, AND LINE BELOW FLU A. TEST WAS READ ON VERITOR AND FLU A POSITIVE WAS THE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18499428 ↗MalfunctionDec 7, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED WHEN USING THE READER KIT FLU A+B 30 TEST HOSPITAL VERITOR THE USER VISUALLY INSPECTS THE CARTRIDGE AND QUESTIONS THE RESULT. THE RESULT WAS VISUALLY READ POSITIVE FOR FLU A+ AND THE ANALYZER GAVE A FLU B+ RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18286970 ↗MalfunctionDec 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR THERE WAS A DISCREPANT RESULT. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18265319 ↗MalfunctionOct 5, 2023False Positive Result; False Positive Result
REPORT 4 OF 4 IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A. DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? RESULT READ BY THE ANALYZER. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 4 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17877322 ↗MalfunctionOct 5, 2023False Positive Result; False Positive Result
REPORT 1 OF 4 IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR PATIENT SAMPLE WAS READ AS POSITIVE HOWEVER PCR CONFIRMATORY TESTING WAS NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? RESULT READ BY THE ANALYZER WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 4 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17877320 ↗MalfunctionOct 5, 2023False Positive Result; False Positive Result
REPORT 3 OF 4. IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A. DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? RESULT READ BY THE ANALYZER. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 4 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17877319 ↗MalfunctionOct 5, 2023False Positive Result; False Positive Result
REPORT 2 OF 4: IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A. DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? RESULT READ BY THE ANALYZER. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 4 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17877318 ↗MalfunctionOct 3, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS THE 4TH OF 4 PATIENTS TESTED AT THIS SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 8 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17863014 ↗MalfunctionOct 3, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS THE 1ST OF 4 PATIENTS TESTED AT THIS SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 8 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17863012 ↗MalfunctionOct 3, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS 2ND OF 4 PATIENTS TESTED AT THIS SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 8 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17863011 ↗MalfunctionOct 3, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE WITH BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS THE 3RD OF 4 PATIENTS TESTED AT THIS SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCREPANT/FALSE POSITIVE RESULTS FLU A PCR CONFIRMATORY TESTING PERFORMED BY THE STATE LAB FOR A TOTAL OF 8 SAMPLES WHICH ALL WERE NEGATIVE FOR FLU A BY PCR BUT POSITIVE ON THE VERITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17863010 ↗
Other Devices detecting influenza A, B, and C virus antigens devices
- BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit 256045Becton, Dickinson And Company · Devices detecting influenza A, B, and C virus antigens251 reports
- ID NOW Influenza A & B 2 427-000Alere Scarborough, Inc. · Devices Detecting Influenza A, B, And C Virus Antigens3 recalls2 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.
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