BinaxNOW® Malaria 665-025Recalls & reported problems
Alere Scarborough, Inc. · For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10811877010378), received between Mar 25, 2026 and Mar 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (3 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.
Reports received per month
Most reported problems
Device problems
- False Negative Result3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026False Negative Result
THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS OBTAINED WITH BINAXNOW MALARIA TESTS ON A SINGLE PATIENT ACROSS MULTIPLE TESTING DATES. THIS MANUFACTURER REPORT PERTAINS TO TEST ONE (1) OF THE THREE (3) TESTS. THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW MALARIA TEST PERFORMED ON (B)(6) 2026 ON A WHOLE BLOOD SAMPLE. SUBSEQUENT CONFIRMATION TESTING WAS CONDUCTED VIA MICROSCOPY AND PCR ON WHOLE BLOOD SAMPLES ON (B)(6) 2026, BOTH OF WHICH YIELDED POSITIVE RESULTS. ACCORDING TO THE CUSTOMER, THE DELAYED DETECTION OF MALARIA RESULTED IN DELAYED IDENTIFICATION OF THE INFECTION, AND TREATMENT FOR A POSSIBLE PLASMODIUM OVALE/VIVAX INFECTION WAS INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688115 ↗MalfunctionMar 25, 2026False Negative Result
THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS OBTAINED WITH BINAXNOW MALARIA TESTS ON A SINGLE PATIENT ACROSS MULTIPLE TESTING DATES. THIS MANUFACTURER REPORT PERTAINS TO TEST THREE (3) OF THE THREE (3) TESTS. THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW MALARIA TEST PERFORMED ON (B)(6) 2026 ON A WHOLE BLOOD SAMPLE. SUBSEQUENT CONFIRMATION TESTING WAS CONDUCTED VIA MICROSCOPY AND PCR ON WHOLE BLOOD SAMPLES ON (B)(6)2026 AND (B)(6)2026, BOTH OF WHICH YIELDED POSITIVE RESULTS. ACCORDING TO THE CUSTOMER, THE DELAYED DETECTION OF MALARIA RESULTED IN DELAYED IDENTIFICATION OF THE INFECTION, AND TREATMENT FOR A POSSIBLE PLASMODIUM OVALE/VIVAX INFECTION WAS INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688109 ↗MalfunctionMar 25, 2026False Negative Result
THE CUSTOMER REPORTED THREE (3) FALSE NEGATIVE RESULTS OBTAINED WITH BINAXNOW MALARIA TESTS ON A SINGLE PATIENT ACROSS MULTIPLE TESTING DATES. THIS MANUFACTURER REPORT PERTAINS TO TEST TWO (2) OF THE THREE (3) TESTS. THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW MALARIA TEST PERFORMED ON (B)(6) 2026 ON A WHOLE BLOOD SAMPLE. SUBSEQUENT CONFIRMATION TESTING WAS CONDUCTED VIA MICROSCOPY AND PCR ON WHOLE BLOOD SAMPLES ON (B)(6) 2026, BOTH OF WHICH YIELDED POSITIVE RESULTS. ACCORDING TO THE CUSTOMER, THE DELAYED DETECTION OF MALARIA RESULTED IN DELAYED IDENTIFICATION OF THE INFECTION, AND TREATMENT FOR A POSSIBLE PLASMODIUM OVALE/VIVAX INFECTION WAS INITIATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688108 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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