BINAXNOW MALARIA 25T US
Received Mar 25, 2026 · Event occurred Feb 23, 2026
Report 1221359-2026-00037 · MDR key 24688108
Device
Generic name
Plasmodium Spp. Detection Reagents
Manufacturer
Abbott Diagnostics Scarborough, Inc.Catalog number
665-025
Lot number
0000914228
Product problems
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.
Description of Event or Problem
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.