Alere Determine HIV–1/2 Ag/Ab ComboRecalls & reported problems across all models
Alere Scarborough, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 265
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 2 models of Alere Determine HIV–1/2 Ag/Ab Combo by Alere Scarborough, Inc. in the FDA's device registry (GUDID). Together they are named in 265 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2017 and Oct 7, 2022 — classified as 8 injuries, 257 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (236 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Alere Determine HIV–1/2 Ag/Ab Combo problems
Device problems
- False Positive Result236
- Incorrect, Inadequate or Imprecise Result or Readings20
- False Negative Result13
- Non Reproducible Results12
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient203
- No Information148
- Pregnancy56
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient9
- HIV, Human Immunodeficiency Virus4
- Cancer2
- Anxiety1
Alere Determine HIV–1/2 Ag/Ab Combo models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2648Test, Hiv Detection238 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2649Test, Hiv Detection27 reports
Recent Alere Determine HIV–1/2 Ag/Ab Combo adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2022False Positive Result; False Positive Result
THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH DETERMINE HIV 1/2 AG/AB COMBO PERFORMED ON AN AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE. THIS MFR. REPORT ADDRESSES TEST RESULTS TWO (2) OF TWO (2). ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15565673 ↗MalfunctionOct 7, 2022False Positive Result; False Positive Result
THE CONSUMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH DETERMINE HIV 1/2 AG/AB COMBO PERFORMED ON AN AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE. THIS MFR. REPORT ADDRESSES TEST RESULTS ONE (1) OF TWO (2). ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15565666 ↗MalfunctionSep 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T FOR TWO PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT 2 OF 2. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST ON (B)(6) 2022 . CONFIRMATORY TESTING AT LAB CORP WAS NOT PERFORMED DUE TO SPECIMEN ISSUE. ALSO CUSTOMER CONFIRMED PATIENT WAS PREGNANT AND TEST WAS PERFORMED BEFORE DELIVERY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15348145 ↗MalfunctionSep 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T FOR TWO PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT 1 OF 2. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST ON (B)(6) 2022 . CONFIRMATORY TESTING AT LAB CORP WAS PERFORMED AND GENERATED A NEGATIVE RESULT, ALSO CUSTOMER CONFIRMED PATIENT WAS PREGNANT AND TEST WAS PERFORMED BEFORE DELIVERY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15348142 ↗MalfunctionAug 9, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON UNKNOWN DATE. CONFIRMATION TESTING GENERATED (PLATFORM:QUEST LAB) A NEGATIVE RESULT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15192323 ↗MalfunctionAug 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES FALSE POSITIVE 2 OF 5. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15151394 ↗MalfunctionAug 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES FALSE POSITIVE 5 OF 5. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15151381 ↗MalfunctionAug 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES FALSE POSITIVE 3 OF 5. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15151318 ↗MalfunctionAug 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES FALSE POSITIVE 1 OF 5. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15151261 ↗MalfunctionAug 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES FALSE POSITIVE 4 OF 5. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15151258 ↗MalfunctionAug 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T FOR THREE PATIENTS PERFORMED ON MULTIPLE DATES. THIS MFR. REPORT ADDRESSES PATIENT 2 OF 3. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST ON (B)(6) 2022. CONFIRMATORY TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT, ALSO CUSTOMER CONFIRMED PATIENT WAS PREGNANT AND TEST WAS PERFORMED BEFORE DELIVERY. AS PER CUSTOMER NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15149940 ↗MalfunctionAug 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T FOR THREE PATIENTS PERFORMED ON MULTIPLE DATES. THIS MFR. REPORT ADDRESSES PATIENT 3 OF 3. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST ON (B)(6) 2022 . CONFIRMATORY TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. AS PER CUSTOMER NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15149857 ↗MalfunctionAug 2, 2022False Positive Result; False Positive Result
THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T FOR THREE PATIENTS PERFORMED ON MULTIPLE DATES. THIS MFR. REPORT ADDRESSES PATIENT 1 OF 3. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST ON (B)(6) 2022 . CONFIRMATORY TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT, ALSO CUSTOMER CONFIRMED PATIENT WAS PREGNANT AND TEST WAS PERFORMED BEFORE DELIVERY. AS PER CUSTOMER NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15149799 ↗MalfunctionJul 15, 2022False Positive Result; False Positive Result
A CUSTOMER REPORTED NINE (9) FALSE POSITIVE RESULTS WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. THIS REPORT REPRESENTS FOUR TEST (4) OF NINE (9) FALSE POSITIVE (AG/AB NOT SPECIFIED) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS REPORTED FROM THE CUSTOMER. CONFIRMATION TESTING WITH THE ABBOTT ARCHITECT WAS NEGATIVE/NONREACTIVE. THE PATIENT WAS REPORTED AS A PREGNANT FEMALE. PATIENT SAMPLE TYPE, TREATMENT AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WAS NOT SUCCESSFUL.THIS EVENT IS CONSIDERED A MALFUNCTION DUE TO UNKNOWN TREATMENT AND THE RISK OF SHORT AND MEDIUM-TERM TOXICITY TO THE FETUS BEING UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15028494 ↗InjuryJun 24, 2022False Positive Result; False Positive Result
THE CONSUMER REPORTED A (B)(6) RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST PERFORMED ON 14OCT2021. CONFIRMATION TESTING WAS PERFORMED USING BIORAD HIV COMBO AG/AB EIA, GENERATED A (B)(6) RESULT. THE CUSTOMER STATED THERE WAS A POSSIBLE C-SECTION DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS A LIVE BIRTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14804578 ↗
Other Alere Scarborough, Inc. products
All Alere Scarborough, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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