MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW MALARIA 25T US; PLASMODIUM SPP. DETECTION REAGENTS

Catalog Number	665-025
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
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.

• Brand Name: BINAXNOW MALARIA 25T US
• Common Device Name: PLASMODIUM SPP. DETECTION REAGENTS
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 24688109
• Report Number: 1221359-2026-00038
• Device Sequence Number: 9976803
• Product Code: OAX
• UDI-Device Identifier: 10811877010378
• UDI-Public: (01)10811877010378(17)260314(10)0000914228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2026
• Device Catalogue Number: 665-025
• Device Lot Number: 0000914228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown