Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2648Recalls & reported problems

Summary

The FDA's MAUDE database contains 238 adverse event reports that list this exact device (DI 10811877010293), received between Oct 19, 2017 and Oct 7, 2022 — classified as 7 injuries, 231 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (210 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 238 reports, 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 ↗
• MalfunctionJun 24, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T ON SEPARATE DATES. THIS REPORT IS FOR PATIENT TWO (2) OF TWO (2). THE PATIENT, WHO WAS PREGNANT, RECEIVED A POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T USING A SERUM SAMPLE ON (B)(6) 2022. AN IMMUNOASSAY TEST (SIEMENS ATELLICA) WAS PERFORMED AT A THIRD-PARTY LABORATORY WHICH GENERATED A NEGATIVE RESULT. THE BABY WAS DELIVERED WITH NO COMPLICATIONS AND MOTHER AND BABY WERE DISCHARGED. PER THE CUSTOMER, ADDITIONAL INFORMATION WAS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800418 ↗
• MalfunctionJun 24, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T ON SEPARATE DATES. THIS REPORT IS FOR PATIENT ONE (1) OF TWO (2). THE PATIENT, WHO WAS PREGNANT, RECEIVED A POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO 25T USING A SERUM SAMPLE ON (B)(6) 2021. AN IMMUNOASSAY TEST (SIEMENS ATELLICA) WAS PERFORMED AT A THIRD-PARTY LABORATORY WHICH GENERATED A NEGATIVE RESULT. THE BABY WAS DELIVERED WITH NO COMPLICATIONS AND MOTHER AND BABY WERE DISCHARGED. PER THE CUSTOMER, ADDITIONAL INFORMATION IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800412 ↗
• MalfunctionMay 31, 2022False Positive Result; False Positive Result

  THE CONSUMER REPORTED FALSE POSITIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST PERFORMED,THIS REPORT ADDRESSES LOT 166679 AND IS ONE OF TWO. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548436 ↗
• MalfunctionMay 31, 2022False Positive Result; False Positive Result

  THE CONSUMER REPORTED FALSE POSITIVE RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST PERFORMED,THIS REPORT ADDRESSES LOT 170854 AND IS TWO (2) OF TWO (2) . ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548435 ↗
• MalfunctionApr 15, 2022False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T TEST PERFORMED ON (B)(6) 2022. PCR CONFIRMATION TESTING GENERATED A POSITIVE RESULT. CONSUMER CONFIRMED THAT THE INITIAL DETERMINE COMBO HIV RAPID TEST GAVE A NEGATIVE RESULT, THE CLIENT WAS NOT IMMEDIATELY LINKED TO HIV RELATED MEDICAL CARE WITHIN 72 HOURS OF HIV DIAGNOSIS AND START ART. CLIENT'S MEDICAL CARE HAS BEEN DELAYED PENDING THE RESULT OF CONFIRMATORY TESTING THUS DELAYING THE START OF ART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120470 ↗
• MalfunctionOct 22, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) ANTIBODY (AB) RESULT ON AN EDTA WHOLE BLOOD SAMPLE WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. REPEAT TESTING ON THE SAME KIT LOT GENERATED (B)(6) RESULTS. CONFIRMATION TESTING WAS (B)(6) TESTING (NOT OTHERWISE SPECIFIED). THE PATIENT WAS REPORTED AS A PREGNANT FEMALE. THE PATIENT RECEIVED ART BASED ON THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. THE CUSTOMER CONFIRMED THAT NO SURGICAL PROCEDURES WERE PERFORMED DUE TO THE (B)(6) RESULT. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683135 ↗
• MalfunctionJul 20, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED (B)(6) RESULTS WITH THE ALERE DETERMINE HIV ¿ AG/AB COMBO TEST PERFORMED ON (B)(6) 2021. THE CUSTOMER REPORTED TESTING A WHOLE EDTA BLOOD SAMPLE AND RETESTING AND RETESTING WAS PERFORMED 2X WITH THE SAME BOX AND 1X ON AN UNOPENED BOX. THREE TOTAL STRIPES WERE STRIPS WERE TESTED. THE SERUM AND PLASMA SAMPLES WERE ADDED TO THE TESTS BY MLA PIPPETTE. BOTH TESTS GENERATED ANTIBODY (AB) (B)(6) RESULTS. CONFIRMATION TESTING WAS PERFORMED AND SENT TO (B)(6) (DIAGNOSTIC METHODOLOGY NOT PROVIDED) GENERATED (B)(6) RESULTS. THE PATIENT WAS NOT KNOWN TO BE (B)(6) AT THE TIME OF TESTING. THE (B)(6) YEAR OLD FEMALE IN LABOR AND DELIVERY. THE TEST WAS PERFORMED PRIOR TO DELIVERY. THE PATIENT DID NOT RECEIVE ART BASED ON THE ALERE DETERMINE HIV-1/2 AG/AB COMBO RESULTS. THE PATIENT EXPERIENCED A 'NORMAL' VAGINAL DELIVERY. THE CUSTOMER REPORTED THAT (B)(6) DRUGS WERE ADMINISTERED TO THE BABY. THERE WAS NO DEATH OR SERIOUS INJURY TO THE PATIENT BASED ON THE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194440 ↗
• MalfunctionMay 25, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED TEN (10) ANTIGEN NEGATIVE RESULTS ON KNOWN POSITIVE LAB SERUM SAMPLES WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE SAMPLES WITH THE HIGHEST VIRAL LOAD WERE REPEATED WITH NEGATIVE RESULTS. THE CUSTOMER REPORTED NO CONFIRMATION METHOD WAS USED AS FACILITY ONLY HAS ALERE DETERMINE HIV 1/2 AG/AB COMBO KIT. ATTEMPTS TO GAIN FURTHER INFORMATION WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881632 ↗
• MalfunctionFeb 10, 2021False Positive Result; False Positive Result

  A CUSTOMER REPORTED THAT FOLLOWING A NEEDLE STICK INVOLVING AN EMPLOYEE, A FALSE POSITIVE RESULT WITH THE ALERE DETERMINE (B)(6) COMBO TEST PERFORMED ON (B)(6) 2021 WAS OBSERVED. FOLLOWING A NEEDLE STICK TO AN EMPLOYEE (NO DETAILS PROVIDED) FROM A NEEDLE USED ON A (B)(6) PATIENT, THE SOURCE PATIENT WAS TESTED WITH THE ALERE DETERMINE (B)(6) COMBO TEST. SERUM SAMPLE WAS ADDED BY 50 ML PIPETTE TO THE TESTS. THE SOURCE PATIENT TEST GENERATED (B)(6) RESULTS. CONFIRMATION TESTING FOR THE SOURCE PATIENT WITH THE (B)(6) TEST PERFORMED ON (B)(6) 2021 GENERATED (B)(6) RESULTS. THE CUSTOMER REPORTED THAT THE SOURCE PATIENT DID NOT HAVE ANY SYMPTOMS AND TESTING THE SOURCE PATIENT WAS PROTOCOL FOR A NEEDLESTICK. THE CUSTOMER WAS UNAWARE OF WHETHER THE SOURCE PATIENT RECEIVED ART. NO ADDITIONAL INFORMATION RELATED TO THE EMPLOYEE WHO EXPERIENCED THE NEEDLE STICK HAS BEEN PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE TEST RESULTS. PER THE ALERE DETERMINE (B)(6) COMBO PRODUCT INSERT LIMITATIONS: (B)(6). WHEN THE SOURCE PATIENT IS (B)(6) AND RECEIVES UNNECESSARY SHORT-TERM ART TREATMENT, THE RISK OF SHORT- AND MEDIUM-TERM TOXICITY WITH THE CURRENT RECOMMENDED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309499 ↗
• MalfunctionDec 23, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 3 (B)(6) ANTIGEN POSITIVES DETERMINE (B)(6) COMBO. THIS REPORT REPRESENTS 3 OF 3. THE CUSTOMER REPORTED (B)(6) DETERMINE (B)(6) COMBO RESULTS WHILE TESTING PREGNANT PATIENTS ON (B)(6) 2020. THE 50 ML EDTA-PLASMA SAMPLE WAS ADDED TO THE TEST BY CONTROL PIPETTE. CONFIRMATION TESTING BY RNA QUANTIFICATION (B)(6) ANTIBODY DIFFERENTIATION AND RNA QUANTITATIVE PCR GENERATED (B)(6) RESULTS. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY BASED ON THE TEST RESULTS. THE CUSTOMER STATED THE PREGNANT WOMAN WAS TESTED PRIOR TO DELIVERY. SHE WAS NOT TREATED WITH ART WHILE PREGNANT; SHE WAS NOT GIVEN ART TREATMENT AT ALL. WITHIN 6 HOURS AFTER BIRTH, THE BABY RECEIVED ART TREATMENT, PER (B)(6) STATE LAW FOR PRESUMED POSITIVES. PER THE ALERE DETERMINE (B)(6) COMBO PRODUCT INSERT LIMITATIONS: A REACTIVE RESULT USING ALERE DETERMINE (B)(6) COMBO SUGGESTS THE PRESENCE OF (B)(6) ANTIGEN AND/OR ANTIBODIES TO (B)(6) IN THE SAMPLE. THE REACTIVE RESULT IS INTERPRETED AS PRELIMINARY (B)(6) FOR (B)(6) ANTIGEN AND/OR ANTIBODIES TO (B)(6). ALERE DETERMINE (B)(6) COMBO IS INTENDED AS AID IN THE DIAGNOSIS OF INFECTION WITH (B)(6). REACTIVE TEST RESULTS SHOULD BE CONFIRMED BY AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066626 ↗