BD Macro-Vue™ RPR™ Card Test, Kit No. 110 275005Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00382902750055), received between Feb 26, 2021 and Mar 14, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHILE TESTING WITH BD MACRO-VUE¿ RPR CARD TEST, NON REACTIVE RESULTS WERE OBTAINED ON SAMPLES THAT PREVIOUSLY TESTED AS REACTIVE AT ANOTHER FACILITY WITH A DIFFERENT RPR TEST. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904316 ↗
• MalfunctionJun 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD MACRO-VUE¿ RPR CARD TEST, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOX 5/6 OF THE REAGENT THAT ARRIVED ON (B)(6) 2023 FROM RPR WAS OPENED, THE FIRST VIAL OF THE THREE THAT COMES IN THE BOX WAS USED. A REACTIVE SAMPLE WAS ANALYZED, WHICH WAS TITRATED, AND IT PRESENTED PERSISTENT AGGLUTINATION UP TO THE TITER 1/1028. GIVEN THIS SITUATION, WE PROCEEDED TO ANALYZE NON-REACTIVE PEEC SAMPLES, AND AT THE TIME OF ANALYSIS, THEY PRESENTED WEAK AGGLUTINATION OR AGGREGATION. A SECOND VIAL FROM THE SAME BOX WAS USED AND THE PROCESS WAS REPEATED, CONCLUDING IN THE SAME SITUATION. FINALLY, A VIAL FROM ANOTHER BOX WAS USED, AND IT WAS REPROCESSED WITH THE NON-REACTIVE PEEC SAMPLE, OBTAINING THE NON-REACTIVE RESULT, CONCLUDING THAT THE REAGENTS IN THAT BOX WERE POSSIBLY DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148372 ↗
• MalfunctionMay 31, 2023False Negative Result; False Negative Result

  REPORT 2 OF 3. IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 INCIDENTS OF RESULTS DISCREPANCY OVER THE LAST FEW MONTHS THERE HAS BEEN SOME INCIDENTS WHEN USING THE DISPOSABLE DISPENSTIRS PATIENTS APPEARED NONREACTIVE, BUT THE PATIENTS HAVE HAD A HISTORY OF BEING REACTIVE. WHEN WE USE THE MLA MICROPIPETTE TO DISPENSE 50 UL THERE IS A SIGNIFICANT INCREASE IN REACTIVITY. ERRONEOUS RESULT WAS REPORTED. A NONREACTIVE RPR WAS REPORTED ON A PATIENT; ONE OF OUR CLIENTS TESTED THAT PATIENT USING THE SAME BD MACRO-VUE RPR KIT AND RECEIVED A REACTIVE RESULT. THERE WAS NO IMPACTED TO THE PATIENT AS OUR CLIENT TREATED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028570 ↗
• MalfunctionMay 31, 2023False Negative Result; False Negative Result

  REPORT 1 OF 3. IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 INCIDENTS OF RESULTS DISCREPANCY OVER THE LAST FEW MONTHS THERE HAS BEEN SOME INCIDENTS WHEN USING THE DISPOSABLE DISPENSTIRS PATIENTS APPEARED NONREACTIVE, BUT THE PATIENTS HAVE HAD A HISTORY OF BEING REACTIVE. WHEN WE USE THE MLA MICROPIPETTE TO DISPENSE 50 UL THERE IS A SIGNIFICANT INCREASE IN REACTIVITY. ERRONEOUS RESULT WAS REPORTED. A NONREACTIVE RPR WAS REPORTED ON A PATIENT; ONE OF OUR CLIENTS TESTED THAT PATIENT USING THE SAME BD MACRO-VUE RPR KIT AND RECEIVED A REACTIVE RESULT. THERE WAS NO IMPACTED TO THE PATIENT AS OUR CLIENT TREATED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028569 ↗
• MalfunctionMay 31, 2023False Negative Result; False Negative Result

  REPORT 3 OF 3. IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 INCIDENTS OF RESULTS DISCREPANCY OVER THE LAST FEW MONTHS THERE HAS BEEN SOME INCIDENTS WHEN USING THE DISPOSABLE DISPENSTIRS PATIENTS APPEARED NONREACTIVE, BUT THE PATIENTS HAVE HAD A HISTORY OF BEING REACTIVE. WHEN WE USE THE MLA MICROPIPETTE TO DISPENSE 50 UL THERE IS A SIGNIFICANT INCREASE IN REACTIVITY. ERRONEOUS RESULT WAS REPORTED. A NONREACTIVE RPR WAS REPORTED ON A PATIENT; ONE OF OUR CLIENTS TESTED THAT PATIENT USING THE SAME BD MACRO-VUE RPR KIT AND RECEIVED A REACTIVE RESULT. THERE WAS NO IMPACTED TO THE PATIENT AS OUR CLIENT TREATED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028565 ↗
• MalfunctionJan 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST LARGE PARTICLES HAVE BEEN AFFECTING INTERPRETATION OF RESULTS. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PARTICLES ARE TOO LARGE, WHICH AFFECTS THE INTERPRETATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16140545 ↗
• MalfunctionDec 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD MACRO-VUE¿ RPR CARD TEST, ERRONEOUS RESULTS WERE OBTAINED. ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIAN, BUT THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEGATIVE CONTROL IS AGAIN CLOUDY AND ALSO SOME OF THE SAMPLE SO IT IS DIFFICULT TO DECIDE IF THE SAMPLE IS POSITIVE OR NEGATIVE. THE AGGLUTINATION REAGENT HAVE THE SAME LOT NUMBER IN ALL KITS. WHEN YOU LOOK AT THE TUBES IN THE KITS THE LIQUID IS WITH SEDIMENTATION /GRANULAR IN IT AND IT DIFFERS HOW MUCH SEDIMENTATION IS BETWEEN TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15901602 ↗
• MalfunctionNov 30, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT BD MACRO-VUE¿ RPR CARD TEST FALSE NEGATIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEGATIVE RESULT THE PARTICLES ARE TOO COARSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887083 ↗
• MalfunctionNov 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD MACRO-VUE¿ RPR CARD TEST THAT THERE IS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE PARTICULAR LOT NUMBER OF BD MACRO-VUE SYPHILIS RPR REAGENT WHICH SEEMS TO BE PERFORMING DIFFERENTLY COMPARED TO EXPECTED PERFORMANCE. LOT NUMBER 2013911 WITH EXPIRY 31/01/2024 SEEMS TO BE MORE GRANULAR IN CONSISTENCY HOWEVER WHEN TESTED WITH A PATIENT SAMPLE IT IS LEADING TO UNDER-REPORTING OF RPR TITRES. WE HAVE COMPARED IT TO A NEWER LOT 2094445 WITH EXPIRY 30/04/24 AND THIS IS PERFORMING AS EXPECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788970 ↗
• MalfunctionNov 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ORDER AND RECEIVED10 (X3 VIALS) OF RPR ANTIGEN ON THE 1/9/2022 WITH LOT #2013911 EXP 31/1/24, CAT #275005. WE WERE USING THIS ANTIGEN LOT # WITHOUT ANY ISSUES UP UNTIL YESTERDAY (26/10/22) WHEN WE NOTICED OUR NEGATIVE CONTROL STARTED LOOKING SLIGHTLY POSITIVE (WEAK AGGLUTINATION). THE NEGATIVE PATIENTS ALSO APPEARED TO BE GIVING THIS SAME PATTERN OF WEAK AGGLUTINATION. TODAY (27/10/22) THE NEGATIVE CLEARLY WAS NOT NEGATIVE ALONG WITH MANY OF OUR PATIENT SAMPLES. WE OPENED A NEW VIAL OF ANTIGEN FROM THE SAMPLE PACKAGE OF 3 AND OBTAINED THE SAME RESULTS. WE THEN OPEN A NEW VIAL FROM ANOTHER PACKAGE AND AGAIN GOT THE SAME RESULTS (WEAKLY POSITIVE NEG CONTROL). THIS IS THE STAGE I CONTACTED MICHELLE KERR FROM BD ABOUT THE OBSERVATIONS WE WERE SEEING TO CHECK IF ANY OTHER LABS HAD REPORTED A SIMILAR ISSUE. AFTER FURTHER DISCUSSIONS WITH MICHELLE WE DECIDED TO TEST ALL THE UNOPENED PACKAGES OF RPR ANTIGEN TO DETERMINE IF THE OBSERVATION ABOUT THE NEGATIVE CONTROL AND NEGATIVE PATIENTS SHOWING A WEAK AGGLUTINATION PATTERN WAS CONSISTENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765920 ↗
• MalfunctionOct 24, 2022False Negative Result; False Negative Result

  IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST RPR PARTICLES ARE LARGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. IT IS A PATIENT SAMPLE. 2. THE REPORT WAS NOT PROVIDED TO THE PATIENT, AND THE USER UNIT USED IT WITH A NEW BATCH NUMBER, AND THE RESULT WAS NORMAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659446 ↗
• MalfunctionSep 9, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST THERE WAS A POSSIBLE FALSE POSITIVE. SOME OF THE SAMPLES WERE REPEATED BUT NOT ALL OF THEM AND SOME PATIENTS WOULD REFLEX TO TP-PA. PATIENT SAMPLE RESULTS WERE NOT REPORTED TO THE CLINICIAN AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING A POSSIBLE FALSE POSITIVE FOR THE PRODUCT 275005 LOT#2013911 CUSTOMER STARTED TESTING WITH LOT 2013911 ON (B)(6) 2022. SHIPMENT WAS RECEIVED IN JUNE AND STORED IN REFRIGERATOR. CUSTOMER SAYS THEY RECEIVED 30 KITS OF AFFECTED LOT. THEY HAVE TESTED AT LEAST 3 KITS AND GOT SAME WEAK REACTIVITY WITH NEGATIVE QC. THE RPR ANTIGEN LOT # 2013911 EXP. 1/31/2024 APPEARS TO BE GRAINIER THAN USUAL THAT EVEN THE NONREACTIVE CONTROL LOOKS LIKE WEAK REACTIVE. IN SPITE OF IT BEING GRAINY, WE CONTINUED TO USE THE ANTIGEN BECAUSE WE DON¿T HAVE ANY OTHER LOT NUMBER TO USE AND WE HAVE A LOT OF PATIENTS TO RUN EVERY DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397337 ↗
• MalfunctionAug 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST THE ANTIGEN SOLUTION IS TOO "GRAINY", AND THE REACTION IS TOO WEAK FOR BOTH CONTROLS AND PATIENT SAMPLES. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RPR 275005 - REACTION IS TOO WEAK. FOLLOWED UP WITH THE CUSTOMER BY PHONE; CUSTOMER STATES THAT ANTIGEN SOLUTION IS TOO "GRAINY", AND THE REACTION IS TOO WEAK FOR BOTH CONTROLS AND PATIENT SAMPLES; CUSTOMER ORDERED 3 KITS OF LOT # 2013911, AND THEY ALREADY USED UP THE FIRST KIT, AND OPENED THE SECOND ONE IN HOPES IT IS BETTER BUT IT IS THE SAME, TOO WEAK AND GRAINY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328171 ↗
• MalfunctionAug 15, 2022False Positive Result; False Positive Result

  IT WAS REPORTED THAT WHILE USING THE BD MACRO-VUE¿ RPR CARD TEST , 2 FALSE POSITIVE RESULTS WERE OBTAINED. THERE WERE NO RESULTS REPORTED TO PHYSICIANS AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS OBSERVED THAT OFF LATE THEY HAVE BEEN FACING MORE REACTIVE SAMPLES THAT IS BEING PICKED UP FROM THEIR DONOR POOL AND WHEN REPEATED WITH TPPA IS NEGATIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229590 ↗
• MalfunctionJun 14, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT HAS BEEN REPORTED THAT THE BD MACRO-VUE¿ RPR CARD TEST HAS BEEN FOUND EXPERIENCING PERFORMANCE ISSUES. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DOUBTFUL RESULTS ARE PRESENTED WITH SOME KITS, SPECIFICALLY WITH THOSE THAT WERE RECEIVED ON 02/10. WE CARRIED OUT A TEST COMPARING REAGENTS RECEIVED ON 03/17 THAT ARE FROM THE SAME LOT (1277599) BUT THE RESULTS ARE CLEARLY DIFFERENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687696 ↗
• MalfunctionJun 8, 2022False Positive Result; False Positive Result

  IT HAS BEEN REPORTED THAT THE BD MACRO-VUE¿ RPR CARD TEST HAS BEEN FOUND PRODUCING A FALSE POSITIVE RESULT. VDRL WAS USED FOR CONFIRMATORY TESTING. THERE WAS REPORT OF MINOR PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PROCESSING OF THIS DISCORDANT EXAM, GAVE US A COMPLETE REACTIVE CARD, WHICH BEING SO IMPROBABLE WAS REPEATED AND GAVE NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639480 ↗
• MalfunctionJun 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD TEST A PHYSICAL DEFECT WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PARTICLES ARE TOO THICK".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941103 ↗
• MalfunctionFeb 26, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PRODUCT LABEL INFORMATION DOES NOT MATCH SDS WITH BD MACRO-VUE¿ RPR CARD TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386568 ↗