BD BBL™ VDRL Antigen 240765Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382902407652), received between Mar 1, 2022 and Jul 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE USING THE BD BBL¿ VDRL ANTIGEN THE SALINE SOLUTION PH IS INCONSISTENT BETWEEN SEVERAL TESTING METHODS, PH TEST STRIPS, PH METER/PROBE, AND MULTISTICK. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824447 ↗
• MalfunctionNov 14, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD BBL¿ VDRL ANTIGEN FALSE NEGATIVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED 1). CAP SURVEY "GA"; MAY 16, 2022; SAMPLE #G-02 WAS "REACTIVE" WHILE WAS SUPPOSED TO BE A NEG. ATTACHED SURVEY SAYS G-02 WAS NON REACTIVE AND THE INTENDED REPORT IS REACTIVE. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS WHICH ASSAYS OR TESTS ARE EXHIBITING ISSUES? 240765. ARE THE VALUES OF THE ASSAYS AVAILABLE? YES. ANALYZER NAME & MODEL #N/A. HOW MANY UNITS (TUBES) AFFECTED? 1. WHAT IS THE FREQUENCY OR OCCURRENCE RATE (1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY TESTS PER DAY ETC.) PT. WHAT WAS METHOD OF DRAW?; STRAIGHT NEEDLE; WINGSET; SYRINGE; LINE; UNSURE/OTHER (PLEASE LIST) PT. IS TUBE FILLED TO STATED VOLUME? UNKNOWN. WHAT WAS ORDER OF DRAW? N/A. HOW MANY TIMES WAS THE TUBE INVERTED? UNKNOWN. HOW WERE TUBES TRANSPORTED? (PNEUMATIC SYSTEM, CARRIER, ETC.) N/A. HOW LONG AFTER COLLECTION WERE TUBES PROCESSED? N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788447 ↗
• MalfunctionMar 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD BBL¿ VDRL ANTIGEN THERE WAS A PERFORMANCE ISSUE. THE PH WAS OUT OF RANGE. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PH OF VDRL BUFFERED SALINE IS OUT OF RANGE. THE BUFFERED SALINE SEEMS TO ONLY BE REACHING A PH OF ~5.3-5.7. CUSTOMER OPENED SEVERAL KITS, USED CURRENT AS WELL AS A BRAND NEW PH METER TO TEST THE PH AND NONE OF THEM REACHED THE REQUIRED 6.0 +/- 1 READING." CUSTOMER HAS CONFIRMED NOT DEVIATING FROM THE PACKAGE INSERT. CUSTOMER CHECKED THE PH WITH PH PAPER IN ADDITION TO OUR USUAL METHOD OF THE EXTECH. THE PH PAPER RESULTS MATCHED THE EXTECH. THE PROBE IS CALIBRATED BEFORE EACH USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13641133 ↗