BD Macro-Vue™ RPR Card Test 275130Recalls & reported problems
Becton, Dickinson And Company · Bulk Kit No. 530: (5,000 qualitative tests), contains: thirty 3 mL amps. antigen, 5,000 BD Dispenstirs™ devices,170 cards with thirty-18 mm circle spots each, test disposables and accessories. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382902751304), received between Sep 21, 2026 and Sep 21, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846896 ↗MalfunctionSep 21, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846043 ↗
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 Antigen Suspension 270333Becton, Dickinson And Company · ANTIGENS, NONTREPONEMAL, ALL1 report
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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