Alere Determine HIV-1/2 Ag/Ab Combo (REF 7D2648)Recalls & reported problems

Summary

The FDA's MAUDE database contains 246 adverse event reports that list this exact device (DI 07290015003735), received between Aug 13, 2015 and Oct 10, 2018 — classified as 5 injuries, 241 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (239 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 246 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED ON AN UNKNOWN SAMPLE TYPE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN.

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

  MAUDE report 7952545 ↗
• MalfunctionSep 25, 2018False Positive Result; False Positive Result

  THIS CASE REPRESENTS 1 OF 4 (B)(6) RESULTS ON UNKNOWN SAMPLE TYPES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO WHICH OCCURRED IN 2017 AND 2018. THE PATIENT WAS CONFIRMED (B)(6) FOR HIV ON A TEST OF UNKNOWN METHODOLOGY. NO EXACT DATE OF OCCURRENCE WAS PROVIDED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT WAS REPORTED AS A PREGNANT FEMALE AND THAT THEIR TREATMENT WAS IMPACTED OR DELAYED BUT NO FURTHER EXPLANATION WAS PROVIDED. ATTEMPTS TO GAIN ADDITIONAL PATIENT INFORMATION WERE NOT SUCCESSFUL.

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

  MAUDE report 7906989 ↗
• MalfunctionSep 25, 2018False Positive Result; False Positive Result

  THIS CASE REPRESENTS THE SECOND OF 4 (B)(6) RESULTS ON UNKNOWN SAMPLE TYPES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO WHICH OCCURRED IN 2017 AND 2018. THE PATIENT WAS CONFIRMED (B)(6) ON A TEST OF UNKNOWN METHODOLOGY. NO EXACT DATE OF OCCURRENCE WAS PROVIDED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT WAS REPORTED AS A PREGNANT FEMALE AND THAT THEIR TREATMENT WAS IMPACTED OR DELAYED BUT NO FURTHER EXPLANATION WAS PROVIDED. ATTEMPTS TO GAIN ADDITIONAL PATIENT INFORMATION WERE NOT SUCCESSFUL.

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

  MAUDE report 7906984 ↗
• MalfunctionJun 18, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED ON A SAMPLE OF UNKNOWN SOURCE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) BY (B)(6). 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); 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 7611271 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FIVE (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS TO AN ALERE REPRESENTATIVE DURING AN ON-SITE VISIT. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. THIS REPORT REPRESENTS ONE OF THE FIVE CASES. A (B)(6) RESULT WAS REPORTED ON A WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. DATE OF EVENT NOT REPORTED. THE PATIENT WAS CONFIRMED HIV NEGATIVE WITH RNA (UNKNOWN METHOD). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. THIS WILL BE FILED AS 5 SEPARATE MDR REPORTS. 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 7603335 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FIVE (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS TO AN ALERE REPRESENTATIVE DURING AN ON-SITE VISIT. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. THIS REPORT REPRESENTS ONE OF THE FIVE CASES. A (B)(6) RESULT WAS REPORTED ON A WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. DATE OF EVENT NOT REPORTED. THE PATIENT WAS CONFIRMED (B)(6) WITH RNA (UNKNOWN METHOD). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. THIS WILL BE FILED AS 5 SEPARATE MDR REPORTS. 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) 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 7603328 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FIVE (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS TO AN ALERE REPRESENTATIVE DURING AN ON-SITE VISIT. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. THIS REPORT REPRESENTS ONE OF THE FIVE CASES. A (B)(6) RESULT WAS REPORTED ON A WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. DATE OF EVENT NOT REPORTED. THE PATIENT WAS CONFIRMED HIV NEGATIVE WITH RNA (UNKNOWN METHOD). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. THIS WILL BE FILED AS 5 SEPARATE MDR REPORTS. 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 7603323 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FIVE (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS TO AN ALERE REPRESENTATIVE DURING AN ON-SITE VISIT. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. THIS REPORT REPRESENTS ONE OF THE FIVE CASES. A (B)(6) RESULT WAS REPORTED ON A WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. DATE OF EVENT NOT REPORTED. THE PATIENT WAS CONFIRMED (B)(6) WITH RNA (UNKNOWN METHOD). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. THIS WILL BE FILED AS 5 SEPARATE MDR REPORTS. 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 7603315 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FIVE (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS TO AN ALERE REPRESENTATIVE DURING AN ON-SITE VISIT. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. THIS REPORT REPRESENTS ONE OF THE FIVE CASES. A (B)(6) RESULT WAS REPORTED ON A WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. DATE OF EVENT NOT REPORTED. THE PATIENT WAS CONFIRMED (B)(6) WITH RNA (UNKNOWN METHOD). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. THIS WILL BE FILED AS 5 SEPARATE MDR REPORTS. 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); 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 7603311 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 3 (B)(6) RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. A (B)(6) AG/AB RESULT WAS REPORTED. UNSPECIFIED (B)(6) RNA CONFIRMATORY TEST WAS (B)(6) . PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 3 SEPARATE MDR REPORTS. 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) 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 7602675 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 3 (B)(6) RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. A (B)(6) AB RESULT WAS REPORTED. UNSPECIFIED (B)(6) RNA CONFIRMATORY TEST WAS (B)(6). PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 3 SEPARATE MDR REPORTS. 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) 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 7602634 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 3 (B)(6) RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. A (B)(6) AB RESULT WAS REPORTED. UNSPECIFIED HIV RNA CONFIRMATORY TEST WAS (B)(6). PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 3 SEPARATE MDR REPORTS. 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 7602631 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 3 (B)(6) (UNKNOWN AG/AB) RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. (B)(4) SERUM HIV 4TH GENERATION TEST WAS NEGATIVE. PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 3 SEPARATE MDR REPORTS. 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); 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 7602304 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 6 (B)(6) AB RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. LABCORP 4TH GENERATION (B)(6) CONFIRMATORY TESTS WERE (B)(6) . PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN.THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 6 SEPARATE MDR REPORTS. 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).; 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 Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 7600443 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 6 (B)(6) AB RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(4) 4TH GENERATION (B)(6) CONFIRMATORY TESTS WERE (B)(6). PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 6 SEPARATE MDR REPORTS. 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 Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 7600441 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 6 (B)(6) AB RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. LABCORP 4TH GENERATION (B)(6) CONFIRMATORY TESTS WERE (B)(6). PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN.THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 6 SEPARATE MDR REPORTS. 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) 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 Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 7600439 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 6 (B)(6) AB RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. LABCORP 4TH GENERATION (B)(6) CONFIRMATORY TESTS WERE (B)(6). PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN.THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 6 SEPARATE MDR REPORTS. 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) 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 Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 7600438 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 6 (B)(6) AB RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. LABCORP 4TH GENERATION (B)(6) CONFIRMATORY TESTS WERE (B)(6). PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 6 SEPARATE MDR REPORTS. 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).; 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 Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 7600434 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 6 (B)(6) AB RESULTS ON FINGERSTICK WHOLE BLOOD SAMPLES TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO, REPORTED BY A CUSTOMER TO AN ALERE REPRESENTATIVE. LABCORP 4TH GENERATION (B)(6) CONFIRMATORY TESTS WERE (B)(6). PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES WERE UNKNOWN.THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THIS WILL BE FILED AS 6 SEPARATE MDR REPORTS. 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); 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 Known Impact Or Consequence To Patient; Pregnancy

  MAUDE report 7600433 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  A (B)(6) AB RESULT WAS REPORTED ON A BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) BY (B)(6), 4TH GENERATION EIA, AND RNA PCR. 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 7598603 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  A NEEDLE STICK OCCURRED AFTER A FEMALE PATIENT GAVE BIRTH AND AS A RESULT OF THE NEEDLE STICK EVENT THE PATIENT WAS TESTED WITH ALERE DETERMINE HIV-1/2 AG/AB COMBO. A (B)(6) AB RESULT WAS REPORTED WITH A SAMPLE ON THE ALERE DETERMINE¿ HIV-1/2 AG/AB COMBO TEST. THE PATIENT SAMPLE WAS SENT FOR CONFIRMATORY TESTING AND CAME BACK (B)(6), HOWEVER DUE TO THE (B)(6) ALERE DETERMINE HIV-1/2 AG/AB COMBO RESULT THE NURSE THAT WAS INVOLVED IN THE NEEDLE STICK WAS PROVIDED PROPHYLACTIC TREATMENT. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. HOWEVER, SINCE THE NURSE THAT WAS INVOLVED WITH THE NEEDLE STICK'S PREGNANCY STATUS AND PATIENT OUTCOME WERE UNKNOWN THIS EVENT IS BEING REPORTED. 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 7598602 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  A NEWBORN INFANT RECEIVED (B)(6) AS A RESULT OF A (B)(6) AB REPORTED ON A VENOUS WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO FROM THE DELIVERING MOTHER. AT THE TIME OF TESTING, THE PATIENT WAS IN ACTIVE LABOR AND WAS LATER CONFIRMED TO BE (B)(6) BY ARUP HIV 1/2 AG/AB AND HIV QUANTITATIVE RNA. THE PATIENT OUTCOME IS 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 7598600 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  A (B)(6) AB RESULT WAS REPORTED ON A BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) BY (B)(6), 4TH GENERATION EIA, AND RNA PCR. 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); 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 7598597 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  A (B)(6) AG RESULT WAS REPORTED ON A BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) BY A 4TH GENERATION EIA, AND RNA PCR. 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 7598479 ↗
• MalfunctionJun 13, 2018False Positive Result; False Positive Result

  A (B)(6) AB RESULT WAS REPORTED ON A BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) BY (B)(6) AND 4TH GENERATION EIA. 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 7598478 ↗