BD Viper™ System 441091Recalls & reported problems
Becton, Dickinson And Company · BD Viper™ System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382904410919), received between Sep 14, 2022 and May 19, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 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 16, 2026.
Most reported problems
Device problems
- False Positive Result2
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2023False Negative Result; False Negative Result
IT WAS REPORTED THAT WHILE USING BD VIPER¿ SYSTEM HAS HAD AN INCREASE OF SALE NEGATIVE SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMED THAT HAS NOTICE AN INCREASE OF FALSE NEGATIVES SAMPLES. THE INTERNAL CONTROLS PASS BUT REPEATING A DUMMY RUN WITH ALREADY KNOWN POSITIVE SAMPLES, ONE BECAME NEGATIVE AND ONE POSITIVE WITH A LOW VALUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16969910 ↗MalfunctionJan 26, 2023False Positive Result; False Positive Result
IT WAS REPORTED THAT WHILE USING THE BD VIPER¿ SYSTEM THAT THERE WAS A FASLE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION THAT CAUSE FALSE POSITIVE RESULTS FOR CT/GC ASSAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251366 ↗MalfunctionSep 14, 2022False Positive Result; False Positive Result
IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CONTAMINATION ON BD VIPER¿ SYSTEM. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "FOR THE PAST THREE DAYS, THE INSTRUMENT HAS BEEN CONTAMINATED WITH GC. THE CUSTOMER HAS TRIED TO EXTENSIVELY DECONTAMINATE THE INSTRUMENT BUT THIS IS STILL SHOWING UP, AND THEY ARE NOW REQUESTING SUPPORT ON THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15419844 ↗
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- BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay 441126Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA5 reports
- Aptima Combo 2® KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATEDHologic, Inc. · DNA-REAGENTS, NEISSERIA3 reports
- Aptima Combo 2® KIT, BX 1 (REFRIG) AC2, 100T, AS, IVDHologic, Inc. · DNA-REAGENTS, NEISSERIA2 reports
- BD Viper™ System Remanufactured 442843Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA2 reports
- Aptima® APTIMA VAGINAL SWAB COLLECTION KITHologic, Inc. · DNA-REAGENTS, NEISSERIA2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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