BD Viper™ System Remanufactured 442843Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382904428433), received between Mar 2, 2022 and Jan 19, 2023 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2023False Positive Result; False Positive Result

  IT WAS REPORTED THAT BD VIPER¿ SYSTEM, REMANUFACTURED HAS BEEN GIVING INCREASED AMOUNT OF POSITIVE RESULTS AFTER A SPILL OCCURRED WHERE WELLS ARE PLACED FOR CONTROLS AND PATIENTS BUT CAN NOT BE REPRODUCED ON SECOND TESTING PLATFORM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING TRAY FROM INSTRUMENT, TRAY WITH STICKY COVERED WAS DROPPED UPSIDE DOWN ONTO 4 STATIONS ON RIGHT SIDE WHERE WELLS ARE PLACED AND SPILLED LIQUID HERE. SINCE THEN, THE CUSTOMER HAS BEEN GETTING INCREASED POSITIVE RESULTS FOR CONTROLS AND PATIENT SAMPLES WHICH CANNOT BE REPRODUCED WITH ANOTHER PLATFORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200660 ↗
• MalfunctionMar 2, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE BD VIPER¿ SYSTEM, REMANUFACTURED PRODUCED A FALSE POSITIVE RESULT FOR CT. THIS WAS REPORTED TO THE CLINICIANS, BUT THE PATIENT WAS NOT TREATED BASED ON THE ERRONEOUS RESULT. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR ADVERSE PATIENT IMPACT. ASSAYS USED: CT/GC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE¿VE HAD RESULT DISCREPANCY ON THE VSP0138, RUN DONE ON THE 18/01/2022." IS THIS AN ISSUE OF FALSE POSITIVE OR FALSE NEGATIVE RESULT? THE RESULT REPORTED WAS FALSE POSITIVE . WHICH ASSAY WAS THIS FOR (CT/ CG/ HPV)? THIS WAS CT/GC ASSAY- CT WAS POSITIVE. WERE INCORRECT RESULTS REPORTED TO THE PHYSICIAN? INCORRECT RESULTS WERE REPORTED TO THE CLINICIAN AND COMPLAINT WAS RAISED. WAS THE PATIENT TREATED BASED OFF ANY INCORRECT RESULT? PATIENT WAS NOT PUT ON TREATMENT, BUT INCIDENT RAISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653924 ↗