Determine™ HIV–1/2 Ag/Ab Combo 7D2648Recalls & reported problems
Alere Scarborough, Inc. · Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Determine HIV-1/2 Ag/Ab Combo test is a blood test for HIV. Its 409 adverse event reports mostly describe false positive results, with some describing false negative and non-reproducible results. The reports include no deaths and 2 injuries. No recalls name this device. Reports fell from 217 in the earlier year to 111 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 409
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 409 adverse event reports that list this exact device (DI 00811877011101), received between Oct 20, 2022 and May 4, 2026 — classified as 2 injuries, 407 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (395 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 Result395
- False Negative Result10
- Non Reproducible Results5
Patient problems
- No Clinical Signs, Symptoms or Conditions408
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 409 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075115 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075114 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075110 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075102 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25075098 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074938 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074937 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074935 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074934 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074932 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074931 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074930 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074929 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074928 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074927 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074926 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074925 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074919 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074895 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074894 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074893 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074892 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074891 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074890 ↗MalfunctionMay 4, 2026False Positive Result
THE CUSTOMER REPORTED ONE-HUNDRED (100) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, NO SPECIFIC PATIENT INFORMATION, INCLUDING DEMOGRAPHICS, TREATMENT, OR IMPACT WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074889 ↗
Other Test, Hiv Detection devices
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2648Alere Scarborough, Inc. · Test, Hiv Detection238 reports
- Elecsys HIV Duo 08836973190Roche Diagnostics GmbH · Test, HIV detection105 reports
- ARCHITECT 2P36-01Abbott GmbH · Test, hiv detection1 recall0 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2649Alere Scarborough, Inc. · Test, Hiv Detection27 reports
- cobas® HIV-1 09040803190Roche Molecular Systems, Inc. · Test, HIV detection27 reports
- VITROS 6842781Ortho Clinical Diagnostics · Test, hiv detection16 reports
- RealTime 6L18-90Abbott Molecular Inc. · Test, hiv detection12 reports
- APTIMA® KIT, MAIN ASSAY, HIV QUANT, 100T, US IVDHologic, Inc. · Test, hiv detection9 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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