Anti-Human-Globulin, Anti-IgG, -C3d; polyspecific 804115100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07611969950652), received between Sep 13, 2017 and May 7, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE DAT (DIRECT ANTI-GLOBULIN TEST) RESULT OF A PROFICIENCY SAMPLE. WITH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D POLYSPECIFIC. THE CUSTOMER STATED THAT THE REACTION WAS SUPPOSED TO BE POSITIVE DUE TO THE IGG SENSITIZATION. THE CUSTOMER PROVIDED A SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING AND ALSO THE PROFICIENCY SAMPLE. THE INVESTIGATION IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14313866 ↗
• MalfunctionMay 7, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE DAT (DIRECT ANTI-GLOBULIN TEST) RESULT OF A PROFICIENCY SAMPLE. WITH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D POLYSPECIFIC. THE CUSTOMER STATED THAT THE REACTION WAS SUPPOSED TO BE POSITIVE DUE TO THE IGG SENSITIZATION. THE CUSTOMER PROVIDED A SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING AND ALSO THE PROFICIENCY SAMPLE. THE INVESTIGATION IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14313842 ↗
• MalfunctionFeb 26, 2020False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO API PROFICIENCY SAMPLES LABELED AS DAT-05 AND DAT-06 WITH ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG, -C3D; POLYSPECIFIC IN THE TUBE METHOD. ACCORDING TO THE REPORT FROM API, ONE SAMPLE SHOULD BE POSITIVE DUE TO COMPLEMENT LOAD AND ONE BECAUSE OF BOTH COMPLEMENT AND IGG LOAD. THE CUSTOMER SO FAR WAS NOT ABLE TO PROVIDE A DATE OF EVENT. THE CUSTOMER ANNOUNCED TO SEND IN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING, OUR QUALITY CONTROL LABORATORY IS STILL WAITING FOR THE SAMPLE. MEANWHILE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D, POLYSPECIFIC FOR POTENCY AND SPECIFICITY. DURING THIS TESTING THE ANTI-IGG PART AS WELL AS THE ANTI-COMPLEMENT PART OF THE AHG WERE TESTED. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE HAD A NEGATIVE IMPACT ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9754747 ↗
• MalfunctionFeb 3, 2020False Negative Result; Defective Component

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO PROFICIENCY SAMPLES WHEN TESTED USING ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG IN THE TUBE METHOD. THE CUSTOMER STATED THAT BOTH SAMPLES WERE SUPPOSED TO YIELD POSITIVE REACTIONS DUE TO THE IGG SENSITIZATION. THE CUSTOMER RETURNED BOTH PROFICIENCY SAMPLES THAT HAD CAUSED FALSE NEGATIVES FOR INVESTIGATIONAL TESTING AND ALSO THE SUPPOSEDLY DEFECTIVE PRODUCT ANTI-HUMAN GLOBULIN ANTI-IGG. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE HAD NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9658894 ↗
• MalfunctionFeb 3, 2020False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO PROFICIENCY SAMPLE WHEN TESTED WITH ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG, -C3D; POLYSPECIFIC IN THE TUBE METHOD. THE CUSTOMER STATED THAT THEY PARTICIPATED IN THREE DIFFERENT CYCLES OF API PROFICIENCY TESTING. THE CUSTOMER STATED THAT THEY PASSED CYCLE 2, BUT FAILED CYCLE 1 AND 3. IN BOTH CASES THE IGG SENSITIZED SAMPLES DAT-02 (CYCLE 1) AND DAT-06 (CYCLE 3) YIELDED FALSE NEGATIVE RESULTS. THE DATE OF EVENT IS NOT KNOWN. THE CUSTOMER RETURNED PROFICIENCY SAMPLES OF CYCLE 3 THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS, BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG, -C3D; POLYSPECIFIC . TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE HAD NEGATIVE INFLUENCES ON THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9658856 ↗
• MalfunctionOct 30, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG, -C3D; POLYSPECIFIC IN THE MANUAL TUBE METHOD. THE CUSTOMER STATED THAT THE PATIENT SAMPLE HAD AN ANTIBODY AND A POSITIVE DIRECT ANTIGLOBULIN TEST (DAT). THE CUSTOMER SENT THE PATIENT SAMPLE FOR ANTIBODY IDENTIFICATION TO AN EXTERNAL LABORATORY AND IS STILL WAITING FOR THEIR RESULT. THE EXTERNAL LABORATORY CONFIRMED THE POSITIVE DAT OF THE PATIENT SAMPLE. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. ADDITIONALLY HE SUBMITTED A SECOND ANTI-HUMAN GLOBULIN (AHG) REAGENT. TESTING OF OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. WHILE WAITING FOR THE REAGENTS AND THE PATIENT SAMPLE SUBMITTED BY THE CUSTOMER OUR QUALITY CONTROL LABORATORY ALREADY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR POTENCY AND SPECIFICITY. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019392 ↗
• MalfunctionAug 29, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE DIRECT ANTIGLOBULIN TEST (DAT) OF A CAP SURVEY SAMPLE WHEN TESTING IN THE MANUAL TUBE METHOD WITH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE CAP SURVEY SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE CAP SURVEY SAMPLE WITH THE COMPLAINT PRODUCT SAMPLE RETURNED BY THE CUSTOMER AND ALSO WITH THEIR RETENTION SAMPLE IN THE DIRECT ANTIGLOBULIN TEST (DAT) AND YIELDED A CORRECTLY POSITIVE RESULT. ADDITIONALLY THE COMPLAINT AND THE RETENTION SAMPLE WERE TESTED FOR POSITIVE AND NEGATIVE SPECIFICITY AND POTENCY. ALL ACCEPTANCE CRITERIA WERE MET FOR BOTH AHG REAGENTS. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825711 ↗
• MalfunctionAug 29, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE DIRECT ANTIGLOBULIN TEST (DAT) OF A CAP SURVEY SAMPLE WHEN TESTING IN THE MANUAL TUBE METHOD WITH ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE CAP SURVEY SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE CAP SURVEY SAMPLE WITH THE COMPLAINT PRODUCT SAMPLE RETURNED BY THE CUSTOMER AND ALSO WITH THEIR RETENTION SAMPLE IN THE DIRECT ANTIGLOBULIN TEST (DAT) AND YIELDED A CORRECTLY POSITIVE RESULT. ADDITIONALLY THE COMPLAINT AND THE RETENTION SAMPLE WERE TESTED FOR POSITIVE AND NEGATIVE SPECIFICITY AND POTENCY. ALL ACCEPTANCE CRITERIA WERE MET FOR BOTH AHG REAGENTS. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825709 ↗
• MalfunctionAug 29, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE DIRECT ANTIGLOBULIN TEST (DAT) OF A CAP SURVEY SAMPLE WHEN TESTED IN THE MANUAL TUBE METHOD WITH ANTI-IGG. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, BUT THE CAP SURVEY SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE CAP SURVEY SAMPLE WITH THEIR RETENTION SAMPLE OF ANTI-IGG AND A REFERENCE LOT THAT THE CUSTOMER HAD USED IN A RETEST. OUR QUALITY CONTROL LABORATORY PERFORMED THE DIRECT ANTIGLOBULIN TEST (DAT) AND YIELDED A CORRECTLY POSITIVE RESULT WITH BOTH ANTI-IGG. ADDITIONALLY THE RETENTION SAMPLE AND THE REFERENCE LOT WERE TESTED FOR POSITIVE AND NEGATIVE SPECIFICITY AND POTENCY. ALL ACCEPTANCE CRITERIA WERE MET FOR BOTH ANTI-IGG REAGENTS. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ANTI-IGG FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825686 ↗
• MalfunctionAug 29, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE DIRECT ANTIGLOBULIN TEST (DAT) OF A CAP SURVEY SAMPLE WHEN TESTED IN THE MANUAL TUBE METHOD WITH ANTI-IGG. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, BUT THE CAP SURVEY SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE CAP SURVEY SAMPLE WITH THEIR RETENTION SAMPLE OF ANTI-IGG AND A REFERENCE LOT THAT THE CUSTOMER HAD USED IN A RETEST. OUR QUALITY CONTROL LABORATORY PERFORMED THE DIRECT ANTIGLOBULIN TEST (DAT) AND YIELDED A CORRECTLY POSITIVE RESULT WITH BOTH ANTI-IGG. ADDITIONALLY THE RETENTION SAMPLE AND THE REFERENCE LOT WERE TESTED FOR POSITIVE AND NEGATIVE SPECIFICITY AND POTENCY. ALL ACCEPTANCE CRITERIA WERE MET FOR BOTH ANTI-IGG REAGENTS. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ANTI-IGG FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825684 ↗
• MalfunctionJul 10, 2018False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE DIRECT ANTIGLOBULIN TEST (DAT) OF A PATIENT SAMPLE. THE CUSTOMER HAD TESTED THE PATIENT SAMPLE MANUALLY USING ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG, -C3D; POLYSPECIFIC. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT SAMPLE PROVIDED BY THE CUSTOMER AND ALSO WITH THEIR RETENTION SAMPLE IN THE DIRECT ANTIGLOBULIN TEST (DAT) AND YIELDED A CORRECTLY POSITIVE RESULT. ADDITIONALLY, THE COMPLAINT AND THE RETENTION SAMPLE WERE TESTED FOR POSITIVE AND NEGATIVE SPECIFICITY AND POTENCY. ALL ACCEPTANCE CRITERIA WERE MET FOR BOTH AHG REAGENTS. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ANTI-HUMAN GLOBULIN ANTI-IGG, -C3D; POLYSPECIFIC FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7672741 ↗
• MalfunctionSep 14, 2017False Negative Result

  THE CUSTOMER REPORTED THAT HE GOT FALSE NEGATIVE TEST RESULTS WHEN PERFORMING TUBE TESTINGS WITH KNOWN SAMPLES BY USING THE PRODUCT AHG ANTI-IGG,-C3D , LOT # 8630053-01 FOR TESTING, A CROSSMATCH OF A (B)(6) SURVEY SHOWED A FALSE NEGATIVE TEST RESULT. FURTHERMORE A CONFIRMED ANTI D POSITIVE SAMPLE SHOWED NEGATIVE TEST RESULTS WHEN USING THE COMPLAINED PRODUCT AHG WITH THE PRODUCT SERACLONE ANTI-D IN TUBE TESTING. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT ( AHG ANTI-IGG,-C3D , LOT # 8630053-01), THREE CAP SAMPLES AND THE BLOOD SAMPLE THAT HAD CAUSED FALSE NEGATIVE RESULTS FOR INVESTIGATIONAL TESTINGS. THE QUALITY CONTROL LABORATORY INVESTIGATION IS STILL ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864093 ↗
• MalfunctionSep 13, 2017False Negative Result

  THE CUSTOMER REPORTED THAT HE GOT FALSE NEGATIVE TEST RESULTS WHEN PERFORMING TUBE TESTINGS WITH KNOWN SAMPLES BY USING THE PRODUCT AHG ANTI-IGG,-C3D , LOT # 8630053-01 FOR TESTING, MANUAL TUBE TESTING PERFORMING A CROSSMATCH WITH J-9 AND J-13 (CAP SURVEY). THE CROSSMATCH WAS COMPATIBLE AND GAVE A NEGATIVE REACTION. THE CUSTOMER FAILED THE CAP SURVEY BY REPORTING A NEGATIVE RESULT BUT IT WAS POSITIVE. REPEATING THE CROSSMATCH THE REACTION (UNDER THE MICROSCOPE) WAS WEAKLY POSITIVE. THE CUSTOMER PERFORMED A UNIT CONFIRMATION ON AN A POS. SAMPLE. THE RESULT WAS RH(D) NEGATIVE BUT IT SHOULD HAVE BEEN POSITIVE. THE CUSTOMER RETURNED THE AHG, ANTI-IGG,-C3D, THE CAP SURVEY SAMPLES J-09R, J-09S AND J-13R AS WELL AS A BLOOD SAMPLE (SEGMENT) THAT CAUSED FALSE NEGATIVE TEST RESULTS FOR INVESTIGATIONAL TESTING. THE COMPLAINED AHG SAMPLE RETURNED BY THE CUSTOMER WAS TESTED BY TITRATION IN PARALLEL TO OUR QUALITY CONTROL LABORATORY'S RETAINED SAMPLE AND A REFERENCE LOT. ALL RESULTS WERE AS EXPECTED. THEN CROSSMATCH WAS PERFORMED WITH COMPATIBLE AND INCOMPATIBLE CROSSMATCH TESTING. WE ALSO TESTED THE CAP SURVEY SAMPLES J-13R AND J-09S THAT WERE PROVIDED BY THE CUSTOMER, AND THE RESULT WAS CLEARL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6862005 ↗