Alere Determine HIV-1/2 Ag/Ab Combo (REF 7D2649)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07290015003742), received between Dec 1, 2015 and Jun 14, 2018 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 7 (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS (FINGERSTICK WHOLE BLOOD) REPORTED FROM A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(6) WERE CONFIRMED (B)(6) BY A 4TH GENERATION (B)(6) TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE(S) OF OCCURRENCE ARE 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 7602326 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 7 (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS (FINGERSTICK WHOLE BLOOD) REPORTED FROM A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(6) WERE CONFIRMED (B)(6) BY A 4TH GENERATION (B)(6) TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE(S) OF OCCURRENCE ARE 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 7602317 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 7 (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS (FINGERSTICK WHOLE BLOOD) REPORTED FROM A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(6) WERE CONFIRMED (B)(6) BY A 4TH GENERATION (B)(6) TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE(S) OF OCCURRENCE ARE 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 7602314 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 7 (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS (FINGERSTICK WHOLE BLOOD) REPORTED FROM A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(6) WERE CONFIRMED (B)(6) BY A 4TH GENERATION HIV TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE(S) OF OCCURRENCE ARE 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 7602313 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 7 (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS (FINGERSTICK WHOLE BLOOD) REPORTED FROM A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(6) WERE CONFIRMED (B)(6) BY A 4TH GENERATION (B)(6) TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE(S) OF OCCURRENCE ARE 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 7602311 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 7 (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS (FINGERSTICK WHOLE BLOOD) REPORTED FROM A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(6) WERE CONFIRMED (B)(6) BY A 4TH GENERATION (B)(6) TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE(S) OF OCCURRENCE ARE 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 7602309 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 7 (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS (FINGERSTICK WHOLE BLOOD) REPORTED FROM A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(6 WERE CONFIRMED (B)(6) BY A 4TH GENERATION HIV TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE(S) OF OCCURRENCE ARE 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 7602308 ↗
• MalfunctionJun 14, 2018False Positive Result; False Positive Result

  THIS REPORT REPRESENTS 1 OF 7 (B)(6) ALERE DETERMINE HIV 1/2 AG/AB COMBO PATIENT RESULTS (FINGERSTICK WHOLE BLOOD) REPORTED FROM A CUSTOMER TO AN ALERE REPRESENTATIVE. (B)(6) WERE CONFIRMED (B)(6) BY A 4TH GENERATION (B)(6) TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE DATE(S) OF OCCURRENCE ARE 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 7602307 ↗
• MalfunctionJun 11, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED (B)(6) AG/AB RESULT ON FINGERSTICK SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. CUSTOMER REPEATED TEST TWICE WITH SAME RESULT. GEENIUS (B)(6) CONFIRMATORY TEST WAS (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES 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 7587576 ↗
• MalfunctionJun 8, 2018False Positive Result; False Positive Result

  A (B)(6) AB RESULT WAS REPORTED ON AN EDTA PLASMA SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) BY ABBOTT ARCHITECT. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT'S 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 SCARBOROUGH, INC. (B)(4).

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

  MAUDE report 7583790 ↗
• MalfunctionJun 7, 2018False Positive Result; False Positive Result

  A (B)(6) AG 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) AT QUEST BY AN UNKNOWN METHOD. 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 7579059 ↗
• MalfunctionJun 4, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED ON THE ALERE DETERMINE¿ HIV-1/2 AG/AB COMBO TEST . THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT'S 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)(6), INC., HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(6) TO (B)(6) 2018 AT ALERE (B)(4), INC. ((B)(4)).

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

  MAUDE report 7567083 ↗
• MalfunctionJun 4, 2018False Positive Result; False Positive Result

  CUSTOMER REPORTED CONFLICTING RESULTS ON A FINGERSTICK WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE (B)(6) AG/AB COMBO. THE SAME SAMPLE WAS USED TO PERFORM TWO TESTS. THE FIRST TEST RESULT WAS (B)(6) FOR AG/AB, AND THE SECOND TEST WAS (B)(6). IT IS UNKNOWN HOW MUCH TIME ELAPSED BETWEEN THE TWO TESTS, BUT IT IS POSSIBLE THEY OCCURRED ON THE SAME DAY. A 4TH GENERATION (B)(6) TEST WITH VENIPUNCTURE SAMPLE WAS (B)(6). BASED ON THE INFORMATION AVAILABLE IN THE CASE, IT APPEARS A MALFUNCTION MAY HAVE OCCURRED WITH ONE OF THE TWO CONFLICTING ALERE DETERMINE (B)(6) COMBO TESTS. PATIENT WAS MALE TRANSITIONING TO FEMALE TRANSGENDER INDIVIDUAL, WITH TREATMENT AND PATIENT OUTCOME UNKNOWN. THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT (B)(4).

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

  MAUDE report 7566046 ↗
• MalfunctionMay 30, 2018False Positive Result; False Positive Result

  A (B)(6) AB RESULT WAS REPORTED ON A SERUM SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) USING HIV-1/2 AB DIFF.W/REFLEX TO HIV-1 RNA AT (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT 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 7554806 ↗
• MalfunctionMay 24, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED ON A PLASMA SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) WITH THE (B)(6) 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); HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(6) TO (B)(6) 2018 AT ALERE (B)(4). ((B)(4)).

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

  MAUDE report 7542503 ↗
• MalfunctionMay 24, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED ON A PLASMA SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) 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 (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 7542501 ↗
• MalfunctionMay 24, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED ON A PLASMA SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS CONFIRMED (B)(6) 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)(6); HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(6) TO (B)(6) 2018 AT ALERE (B)(4) ((B)(4)).

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

  MAUDE report 7542499 ↗
• MalfunctionMay 24, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED ON A WHOLE BLOOD (FINGERSTICK) SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. A (B)(6). A (B)(6) TEST WAS (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), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(4) TO (B)(4) 2018 AT ALERE (B)(4), INC. ((B)(4)).

  Patient problems: No Information

  MAUDE report 7542498 ↗
• MalfunctionMay 24, 2018False Positive Result; False Positive Result

  A (B)(6) RESULT WAS REPORTED ON A PLASMA SAMPLE TESTED WITH THE (B)(6) DETERMINE (B)(6). THE PATIENT WAS CONFIRMED (B)(6) WITH THE ABBOTT (B)(6) 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 (B)(6), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(6) 2018 AT (B)(6) INC. ((B)(6)).

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

  MAUDE report 7542493 ↗
• InjuryApr 25, 2016False Positive Result; False Positive Result

  CUSTOMER REPORTED A POTENTIAL (B)(6) FOR A LABOR AND DELIVERY PATIENT . CONFIRMATORY TESTING WAS PERFORMED AND THE (B)(6). DUE TO (B)(6) THE PATIENT UNDERWENT A C-SECTION. THERE WERE NO REPORTED COMPLICATIONS DUE TO THE C-SECTION. THE PATIENT WAS ADVISED NOT TO BREAST FEED THE NEWBORN.

  Patient problems: Misdiagnosis

  MAUDE report 5603819 ↗
• MalfunctionDec 1, 2015False Positive Result

  CUSTOMER REPORTED A POTENTIAL (B)(6) AB RESULT FOR A LABOR AND DELIVERY PATIENT. CONFIRMATORY TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. THERE WERE NO ADVERSE PATIENT OUTCOMES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5256900 ↗
• MalfunctionDec 1, 2015False Positive Result

  CUSTOMER REPORTED A POTENTIAL (B)(6) RESULT FOR A LABOR AND DELIVERY PATIENT. CONFIRMATORY TESTING WAS PERFORMED AND THE RESULT WAS (B)(6). THERE WERE NO ADVERSE PATIENT OUTCOMES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5256892 ↗