BD Macro-Vue™ RPR™ Card Antigen Suspension 270333Recalls & reported problems
Becton, Dickinson And Company · RPR Card Antigen Suspension, 3 mL, ampule, for use with the 18 mm Circle Card Test, Box of three · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30382902703335), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Non Reproducible Results” (1 report).
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
Device problems
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2022Non Reproducible Results; Non Reproducible Results
IT WAS REPORTED THAT WHILE TESTING WITH THE BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION, DISCREPANT RESULTS WERE OBTAINED. THE RESULT WAS POSITIVE WHILE CONFIRMATORY TESTING WITH A COMPETITOR'S REAGENT PRODUCED A NEGATIVE RESULT. POSITIVE RESULT WAS REPORTED OUT; THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IN (B)(6) RECEIVED A (1 : 32) TITER FOR ONE OF THE PATIENT SAMPLES WHILE (B)(6) DID THE RPR TEST FOR THIS PATIENT USING COMPETITOR'S REAGENTS, AND OBTAINED A TITER OF (1 : 1); PATIENT RESULT WAS REPORTED AS (1 : 32);
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13765801 ↗
Other ANTIGENS, NONTREPONEMAL, ALL devices
- BioPlex 2200 12000650Bio-Rad Laboratories, Inc. · ANTIGENS, NONTREPONEMAL, ALL3 recalls1 report
- BD Macro-Vue™ RPR™ Card Test, Kit No. 110 275005Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL18 reports
- BD BBL™ VDRL Antigen 240765Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL3 reports
- BD Macro-Vue™ RPR™ Card Antigen Suspension 270309Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL3 reports
- BD Macro-Vue™ RPR Card Test 275130Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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