Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2649Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10811877010323), received between Feb 22, 2018 and Feb 24, 2020 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (26 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2020False Positive Result; False Positive Result

  A CUSTOMER REPORTED A (B)(6) (AG/AB NOT OTHERWISE SPECIFIED) RESULT ON A SERUM SAMPLE WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. CONFIRMATION TESTING (METHODOLOGY NOT OTHERWISE SPECIFIED) WAS (B)(6). THE PATIENT WAS REPORTED AS A PREGNANT FEMALE (FIRST TRIMESTER). THE CUSTOMER STATED THEY "DIDN'T BELIEVE" ART WAS ADMINISTERED BASED ON THE ALERE DETERMINE HIV-1/2 AG/AB RESULTS. THE CUSTOMER REPORTED THERE WAS NO DEATH, SERIOUS INJURY OR SURGICAL PROCEDURES PERFORMED BASED ON THE RESULTS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. PATIENT TREATMENT AND PATIENT OUTCOME ARE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL PATIENT INFORMATION WERE NOT SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9746731 ↗
• MalfunctionAug 20, 2019False Positive Result; False Positive Result

  A CUSTOMER REPORTED (B)(6) RESULTS WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST BETWEEN (B)(6) 2019 AND (B)(6) 2019. CONFIRMATION TESTING WITH A 4TH GENERATION HIV TEST (NOT OTHERWISE SPECIFIED) WAS NONREACTIVE FOR ALL SIX (6) PATIENTS. THE SAMPLE TYPE AND SPECIFIC RESULT (ANTIBODY/ANTIGEN) WAS NOT REPORTED. PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE NOT REPORTED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8911686 ↗
• MalfunctionJan 7, 2019False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO WITH A PLASMA SAMPLE. THE CUSTOMER REPORTED THAT 2 TESTS WERE PERFORMED. AN ABBOTT ARCHITECT TEST FOR ANTIBODY CONFIRMATION WAS (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT WAS REPORTED AS BEING PREGNANT BUT TREATMENT AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 8221762 ↗
• MalfunctionJan 7, 2019False Positive Result; False Positive Result

  A (B)(6) AB RESULT WAS REPORTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO WITH A PLASMA SAMPLE. THE CUSTOMER REPORTED THAT 2 TESTS WERE PERFORMED. AN ABBOTT ARCHITECT TEST FOR ANTIBODY CONFIRMATION WAS (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT WAS REPORTED AS BEING PREGNANT BUT TREATMENT AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 8221761 ↗
• MalfunctionJan 7, 2019False Positive Result; False Positive Result

  A (B)(6) AB RESULT WAS REPORTED WITH THE ALERE DETERMINE (B)(6) WITH A PLASMA SAMPLE. THE CUSTOMER REPORTED THAT 2 TESTS WERE PERFORMED. AN ABBOTT ARCHITECT TEST FOR ANTIBODY CONFIRMATION WAS (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT WAS REPORTED AS BEING PREGNANT BUT TREATMENT AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 8221760 ↗
• MalfunctionNov 13, 2018False Positive Result; False Positive Result

  TWO (B)(6) RESULTS WERE REPORTED ON A PLASMA SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. (B)(6). THE PATIENT WAS REPORTED AS A PREGNANT FEMALE OF UNKNOWN AGE. IT IS UNKNOWN IF (B)(6) TREATMENT WAS ADMINISTERED. HOWEVER, IT CAN BE CONFIRMED THAT MEDICAL INTERVENTION REGARDING THE PREGNANCY WAS NOT PERFORMED.

  Patient problems: No Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 8066426 ↗
• MalfunctionNov 13, 2018False Positive Result; False Positive Result

  TWO (B)(6) RESULTS WERE REPORTED ON A PLASMA SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. (B)(6). THERE IS NO INFORMATION PROVIDED REGARDING ANTIGEN CONFIRMATORY TESTING. THE PATIENT WAS REPORTED AS A PREGNANT FEMALE OF UNKNOWN AGE. IT IS UNKNOWN IF ART TREATMENT WAS ADMINISTERED. HOWEVER, IT CAN BE CONFIRMED THAT MEDICAL INTERVENTION REGARDING THE PREGNANCY WAS NOT PERFORMED.

  Patient problems: No Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 8066412 ↗
• MalfunctionNov 13, 2018False Positive Result; False Positive Result

  TWO (B)(6) RESULTS WERE REPORTED ON A PLASMA SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. (B)(6). THE PATIENT WAS REPORTED AS A PREGNANT FEMALE OF UNKNOWN AGE. IT IS UNKNOWN IF (B)(6) TREATMENT WAS ADMINISTERED. HOWEVER, IT CAN BE CONFIRMED THAT MEDICAL INTERVENTION REGARDING THE PREGNANCY WAS NOT PERFORMED.

  Patient problems: No Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 8066405 ↗
• MalfunctionAug 2, 2018False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A (B)(6) RESULT ON A FINGERSTICK WHOLE BLOOD SAMPLE TESTED WITH ALERE DETERMINE HIV 1/2 AG/AB COMBO. A SERUM SAMPLE WAS THEN COLLECTED AND SENT TO THE LOCAL LABORATORY FOR CONFIRMATORY TESTING. TWO OF THE THREE RESULTS OBTAINED WERE (B)(6). THE PATIENT WAS REPORTED AS FEMALE, HOWEVER, AGE, PREGNANCY STATUS, TREATMENT, AND PATIENT OUTCOME ARE UNKNOWN.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7743377 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED TWO (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO TEST RESULTS ON TWO DIFFERENT PATIENTS SEEN IN THE EMERGENCY ROOM ON THE SAME NIGHT. DATE OF EVENT NOT REPORTED. THIS REPORT REPRESENTS ONE OF THE TWO OCCURRENCES. A (B)(6) RESULT WAS REPORTED ON A FINGERSTICK WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE TEST WAS REPEATED (FINGERSTICK WHOLE BLOOD) WITH A DIFFERENT LOT (UNKNOWN LOT NUMBER) OF ALERE DETERMINE HIV 1/2 AG/AB COMBO AND OBTAINED A (B)(6) RESULT. IT IS UNKNOWN IF OTHER CONFIRMATION TESTS WERE PERFORMED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. BASED ON THE INFORMATION AVAILABLE IN THE CASE, IT APPEARS A MALFUNCTION MAY HAVE OCCURRED WITH ONE OF THE TWO CONFLICTING ALERE DETERMINE HIV 1/2 AG/AB TESTS. THE INTERNAL RETENTION TESTING DID NOT REPLICATE THE ISSUE WHICH INDICATED THE DEVICE LOT WAS PERFORMING AS EXPECTED. THIS WILL BE FILED AS 2 SEPARATE MDR REPORTS. THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7603327 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED TWO (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO RESULTS ON TWO DIFFERENT PATIENTS SEEN IN THE EMERGENCY ROOM ON THE SAME NIGHT. DATE OF EVENT NOT REPORTED. THIS REPORT REPRESENTS ONE OF THE TWO OCCURRENCES. A (B)(6) RESULT WAS REPORTED ON A FINGERSTICK WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE TEST WAS REPEATED (FINGERSTICK WHOLE BLOOD) WITH A DIFFERENT LOT (UNKNOWN LOT NUMBER) OF ALERE DETERMINE HIV 1/2 AG/AB COMBO AND OBTAINED A (B)(6) RESULT. IT IS UNKNOWN IF OTHER CONFIRMATION TESTS WERE PERFORMED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. BASED ON THE INFORMATION AVAILABLE IN THE CASE, IT APPEARS A MALFUNCTION MAY HAVE OCCURRED WITH ONE OF THE TWO CONFLICTING ALERE DETERMINE HIV 1/2 AG/AB TESTS. THE INTERNAL RETENTION TESTING DID NOT REPLICATE THE ISSUE WHICH INDICATED THE DEVICE LOT WAS PERFORMING AS EXPECTED. THIS WILL BE FILED AS 2 SEPARATE MDR REPORTS. THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7603324 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED A NEWBORN INFANT GIVEN ART (NEBIRAPINE AND ZIDOBUDINE) AS A RESULT OF A (B)(6) AB RESULT ON A PLASMA SAMPLE FROM THE MOTHER THAT WAS TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. INFANT'S GENDER AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7598591 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED A NEWBORN INFANT GIVEN ART (NEVIRAPINE AND ZIDOVUDINE) AS A RESULT OF A (B)(6) AG RESULT ON A PLASMA SAMPLE FROM THE MOTHER THAT WAS TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. INFANT'S GENDER AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7597335 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED A NEWBORN INFANT GIVEN (B)(6) AS A RESULT OF A (B)(6) AB RESULT ON A PLASMA SAMPLE FROM THE MOTHER THAT WAS TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. INFANT'S GENDER AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7597334 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED A NEWBORN INFANT GIVEN ART (NEBIRAPINE AND ZIDOBUDINE) AS A RESULT OF A (B)(6) AG RESULT ON A PLASMA SAMPLE FROM THE MOTHER THAT WAS TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO WHILE IN ACTIVE LABOR. INFANT'S GENDER AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7597324 ↗
• MalfunctionJun 12, 2018False Positive Result; False Positive Result

  A (B)(6) AB RESULT WAS REPORTED ON A FINGERSTICK WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) WITH (B)(6) - RNA - (B)(6) GEN 4 REFLEX GEENIUS TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7592812 ↗
• MalfunctionJun 12, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED A (B)(6) AG/AB RESULT ON A FINGERSTICK WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. PATIENT WAS CONFIRMED (B)(6) BY GEENIUS (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7591062 ↗
• MalfunctionJun 12, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED A (B)(6) AG RESULT ON A SERUM SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. QUEST ABBOTT IMMUNOASSAY WAS PERFORMED BUT RESULTS NOT SPECIFIED. THE PATIENT WAS MALE, NOT KNOWN TO BE (B)(6). TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7591054 ↗
• MalfunctionJun 12, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED THAT AN EMPLOYEE WAS EXPOSED TO BLOOD PRODUCT FROM A SOURCE PATIENT WITH A (B)(6) RESULT ON A SERUM SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE EXPOSED EMPLOYEE WAS NOT TESTED WITH ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE EMPLOYEE WAS STARTED ON POSTEXPOSURE PROPHYLAXIS (PEP) AS A RESULT OF THE PRELIMINARY POSITIVE RESULT FROM THE SOURCE PATIENT. EMPLOYEE GENDER, PREGNANCY STATUS, AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(4) TO (B)(4) 2018 AT ALERE (B)(4), INC. ((B)(4)).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7591053 ↗
• MalfunctionJun 12, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED THAT AN EMPLOYEE WAS EXPOSED TO BLOOD PRODUCT FROM A SOURCE PATIENT WITH A (B)(6) RESULT ON A SERUM SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE EXPOSED EMPLOYEE WAS NOT TESTED WITH ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE EMPLOYEE WAS STARTED ON (B)(6) AS A RESULT OF THE PRELIMINARY (B)(6) RESULT FROM THE SOURCE PATIENT. EMPLOYEE GENDER, PREGNANCY STATUS, AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4), INC. ((B)(4)).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7591051 ↗
• MalfunctionJun 12, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED THAT AN EMPLOYEE WAS EXPOSED TO BLOOD PRODUCT FROM A SOURCE PATIENT WITH A (B)(6) RESULT ON A (B)(6) TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE EXPOSED EMPLOYEE WAS NOT TESTED WITH ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE EMPLOYEE WAS STARTED ON (B)(6) AS A RESULT OF THE PRELIMINARY(B)(6) RESULT FROM THE SOURCE PATIENT. EMPLOYEE GENDER, PREGNANCY STATUS, AND OUTCOME WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4), INC. ((B)(4)).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7591049 ↗
• MalfunctionJun 11, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED (VIA A CUSTOMER SURVEY) A FALSE (B)(6) AB RESULT ON A SERUM SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2AG/AB COMBO. UNSPECIFIED CONFIRMATORY TEST DONE AT QUEST WAS NEGATIVE. THE DATE OF EVENT WAS NOT PROVIDED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE SCARBOROUGH, INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(6) 2018 AT ALERE (B)(6).

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7587587 ↗
• MalfunctionMar 20, 2018False Positive Result; False Positive Result

  A (B)(6) (PLASMA) RESULT WAS OBTAINED WITH THE (B)(6) DETERMINE (B)(6) TEST ON A (B)(6) YEAR OLD LABOR AND DELIVERY PATIENT. THE PATIENT WAS IN ACTIVE LABOR AT THE TIME OF THE TESTING. THERE WAS NO ANTI-RETROVIRAL TREATMENT INITIATED ON THE MOTHER; HOWEVER, THE NEWBORN RECEIVED ONE DOSE OF NEBIRAPINE/ZIDOBUDINE WHICH WAS DISCONTINUED AFTER THE CONFIRMATORY TEST RESULT WAS OBTAINED.

  Patient problems: Pregnancy

  MAUDE report 7356420 ↗
• MalfunctionMar 20, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS OBTAINED WITH THE ALERE DETERMINE HIV ½ AG/AB COMBO TEST ON A (B)(6) LABOR AND DELIVERY PATIENT. THE PATIENT WAS IN ACTIVE LABOR AT THE TIME OF THE TESTING. THE CUSTOMER REPORTED THAT THE MOTHER HAD A C-SECTION WHICH WAS NOT A RESULT OF THE (B)(6) ALERE DETERMINE HIV ½ AG/AB COMBO TEST RESULT . THERE WAS NO ANTI-RETROVIRAL TREATMENT INITIATED ON THE MOTHER; HOWEVER, THE NEWBORN RECEIVED ONE DOSE OF NEBIRAPINE/ZIDOBUDINE WHICH WAS DISCONTINUED AFTER THE CONFIRMATORY TEST RESULT WAS OBTAINED.

  Patient problems: Pregnancy

  MAUDE report 7356419 ↗
• MalfunctionMar 20, 2018False Positive Result; False Positive Result

  A (B)(6) (PLASMA) RESULT WAS OBTAINED WITH THE (B)(6) DETERMINE (B)(6) COMBO TEST ON A (B)(6) YEAR OLD LABOR AND DELIVERY PATIENT. THE PATIENT WAS IN ACTIVE LABOR AT THE TIME OF THE TESTING. THERE WAS NO ANTI-RETROVIRAL TREATMENT INITIATED ON THE MOTHER; HOWEVER, THE NEWBORN RECEIVED ONE DOSE OF NEBIRAPINE/ZIDOBUDINE WHICH WAS DISCONTINUED AFTER THE CONFIRMATORY TEST RESULT WAS OBTAINED.

  Patient problems: Pregnancy

  MAUDE report 7356418 ↗