BD Viper™ LT System 442839Recalls & reported problems
Becton, Dickinson And Company · Instrument Bd Viper LT System · Class 2
Quick summary
This BD Viper LT System is a laboratory instrument that runs nucleic acid amplification tests, including HPV testing, in real time. Most of the 37 reports describe results reading positive when they were not, sometimes with an unusual PCR curve; a few describe inaccurate readings or parts coming loose. There were no deaths and no injuries, and most reports mention no effect on the patient. Reports rose from 3 in the earlier 12 months to 18 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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00382904428396), received between Oct 20, 2020 and Apr 11, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (26 reports).
2 other recalls cover devices cleared under the same FDA submission (K140447); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result26
- Incorrect, Inadequate or Imprecise Result or Readings5
- Structural Problem3
- False Negative Result2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 10 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851745 ↗MalfunctionApr 11, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 3 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851744 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 6 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844499 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 5 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844490 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 12 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844167 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 7 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844160 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 4 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844072 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 2 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844070 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 9 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844015 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 8 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839102 ↗MalfunctionApr 10, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 11 OF 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839101 ↗MalfunctionApr 9, 2026False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A FALSE POSITIVE HPV PATIENT RESULT WITH AN UNUSUAL PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832413 ↗MalfunctionMar 5, 2026False Positive Result
IT WAS REPORTED THAT DURING THE USE OF THE BD VIPER¿ LT SYSTEM, A TRIPLE FALSE POSITIVE HPV 16,18,45 PATIENT RESULT WAS OBTAINED ON ONE POSITION OF RUN. SAMPLE WAS REPEATED ON A DIFFERENT POSITION AND WAS HPV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24515746 ↗MalfunctionMar 5, 2026False Positive Result
IT WAS REPORTED THAT DURING THE USE OF THE BD VIPER¿ LT SYSTEM, A TRIPLE FALSE POSITIVE HPV 16,18,45 PATIENT RESULT WAS OBTAINED ON ONE POSITION OF RUN. SAMPLE WAS REPEATED ON A DIFFERENT POSITION AND WAS HPV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24515453 ↗MalfunctionMar 5, 2026False Positive Result
IT WAS REPORTED THAT DURING THE USE OF THE BD VIPER¿ LT SYSTEM, A TRIPLE FALSE POSITIVE HPV 16,18,45 PATIENT RESULT WAS OBTAINED ON ONE POSITION OF RUN. SAMPLE WAS REPEATED ON A DIFFERENT POSITION AND WAS HPV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24515282 ↗MalfunctionMar 4, 2026False Positive Result
IT WAS REPORTED THAT DURING THE USE OF THE BD VIPER¿ LT SYSTEM, A TRIPLE FALSE POSITIVE HPV 16,18,45 PATIENT RESULT WAS OBTAINED ON ONE POSITION OF RUN. SAMPLE WAS REPEATED ON A DIFFERENT POSITION AND WAS HPV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24511298 ↗MalfunctionMar 4, 2026False Positive Result
IT WAS REPORTED THAT DURING THE USE OF THE BD VIPER¿ LT SYSTEM, A TRIPLE FALSE POSITIVE HPV 16,18,45 PATIENT RESULT WAS OBTAINED ON ONE POSITION OF RUN. SAMPLE WAS REPEATED ON A DIFFERENT POSITION AND WAS HPV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506140 ↗MalfunctionNov 19, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597151 ↗MalfunctionOct 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING USE OF BD VIPER¿ LT SYSTEM, A CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEA CONTAMINATION OCCURRED, WHICH GAVE AN UNSPECIFIED NUMBER OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23280980 ↗MalfunctionJun 18, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD VIPER¿ LT SYSTEM, A FALSE POSITIVE PATIENT RESULT FOR HPV GENOTYPE 16 WAS OBTAINED. PHYSICIAN AND PATIENT HAD DOUBTS ABOUT RESULT AND A NEW TEST WAS REQUESTED. SECOND SAMPLE WAS COLLECTED AND RETESTED, AND THE RESULT WAS HPV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287638 ↗MalfunctionApr 30, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING USE OF THE BD VIPER¿ LT SYSTEM, ABOUT 30 FALSE POSITIVE PATIENT RESULTS WERE OBTAINED ON THE CT/GC/TV ASSAY. TESTS WERE REPEATED ON VIPER LT AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937898 ↗MalfunctionAug 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD VIPER¿ LT SYSTEM, THERE WAS ONE FALSE POSITIVE RESULT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VIPER LT IS SHOWING CT SCORE WHEN RESULTING HPV THIN PREP. CUSTOMER IS DOING VERIFICATION IN THE VIPER LT FOR HPV WITH THIN PREP. VIPER IS SHOWING CT SCORE IN ALL THE POSITIVE RESULTS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17568387 ↗MalfunctionAug 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT WHILE USING BD ONCLARITY HPV ASSAY, THERE WAS CONTAMINATION OF ONE BOX OF PLATES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS CONTAMINATION DUE TO INSTRUMENT ISSUE WHILE USING CAT 441990 LOT 3132981."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17547454 ↗MalfunctionAug 8, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD VIPER¿ LT SYSTEM FALSE POSITIVE RESULTS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17484816 ↗MalfunctionJul 13, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING BD VIPER¿ LT SYSTEM THERE WAS A FALSE POSITIVE OF ONE PATIENT SAMPLE. THERE WAS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE HAVE BEEN SEVERAL INSTANCES OF DISCREPANT POSITIVE RESULTS ON THE VIPER LT. THE RESULT WAS POSITIVE FOR CT ON THE VIPER LT BUT NEGATIVE ON THE CEPHEID GENEEXPERT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17317056 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K140447. One submission often covers many models, so check the product and lot details in each record.
- Z-1866-2017 · Dec 14, 2015 · TerminatedBD Viper LT software, version 3.00H
- Z-1816-2015 · Nov 7, 2014 · TerminatedBD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae
Other real time Nucleic acid amplification system devices
- BD MAX™ System 441916Becton, Dickinson And Company · real time Nucleic acid amplification system2 recalls1,109 reports
- Alinity m 08N53-002Abbott Molecular Inc. · real time Nucleic acid amplification system4 recalls950 reports
- BD PCR Cartridge 437519Becton, Dickinson And Company · real time Nucleic acid amplification system1 recall140 reports
- BD MAX™ Enteric Viral Panel 443985Becton, Dickinson And Company · real time Nucleic acid amplification system1 recall135 reports
- Verigene® Processor SP 10-0000-07Nanosphere, Inc. · Real Time Nucleic Acid Amplification System3 recalls0 reports
- BD MAX™ StaphSR 443419Becton, Dickinson And Company · real time Nucleic acid amplification system2 recalls1 death44 reports
- Revogene 610210Meridian Bioscience, Inc. · Real Time Nucleic Acid Amplification System2 recalls10 reports
- FilmArray® BCID Panel RFIT-ASY-0126Biofire Diagnostics, LLC · Real Time Nucleic Acid Amplification System2 recalls2 deaths4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.