Anti-Human Globulin Anti-IgG Solidscreen II 806516100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07611969951437), received between Aug 24, 2016 and May 15, 2025 — classified as 1 death, 5 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF HER POSITIVE CONTROL, USING AHG ANTI-IGG SOLIDSCREEN II ON HER TANGO INFINITY INSTRUMENT. UPON REPEATING THE CONTROL, THE RESULT WAS 1+ POSITIVE. A PATIENT/DONOR SAMPLE WAS TESTED BEFORE RUNNING THE FAILED QC, BUT THE SAMPLE WAS NOT VALIDATED. THIS ACTION WAS APPROPRIATE BECAUSE THE QC HAD FAILED. WE CAN CONFIRM THAT NO PATIENT OR DONOR SAMPLES WERE IMPACTED OR AFFECTED BY THIS INCIDENT. THE CUSTOMER CHANGED THE AHG BOTTLE, AFTER WHICH THE CONTROL RESULTS RETURNED TO 4+ AS EXPECTED. ONE OF OUR FIELD SERVICE ENGINEERS WAS ON-SITE TO CHECK THE AFFECTED TANGO INFINITY INSTRUMENT. THE ENTIRE NEEDLE RINSING PROCESS IN THE WASHING STATION WAS CHECKED AND NO ISSUES FOUND WHICH MIGHT HAVE CAUSED THE FALSE NEGATIVE RESULT. NO PIPETTING OR DISPENSING ERRORS WERE DETECTED. OUR QUALITY CONTROL LABORATORY CHECKED THEIR RETENTION SAMPLES OF THE SAME BATCHES AS THE PRODUCTS USED AT THE CUSTOMER'S SITE FOR TESTING. TESTING WAS CONDUCTED AS FOLLOWS: PARALLEL TESTING OF ANOTHER AHG ANTI-IGG LOT WITH COOMBSCELL E SHOWED NO DIFFERENCE IN TITER. TESTING OF SCII CONTROL, SCII CONTROL B, AND TWO DONORS WITHOUT ANTIBODIES WITH BIOTESTCELL 3 ON THE TANGO IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027407 ↗
• MalfunctionDec 13, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF HER SOLIDSCREEN II POSITIVE CONTROL FOR ANTIBODY SCREENING TESTS WHEN USED ON ONE OF THEIR TANGO INFINITY INSTRUMENTS. THE SAME ALIQUOT WAS USED ON THE CUSTOMER'S SECOND INSTRUMENT AND PASSED 4+ ON BOTH CELLS. THE CUSTOMER RAN TWICE AND BOTH TIMES THE RESULT WAS NEGATIVE ON THE FIRST TANGO INFINITY. AFTER THE CUSTOMER EXCHANGED THE AHG ANTI-IGG SOLIDSCREEN II BOTTLE, THE QUALITY CONTROL WAS PASSED. THE CUSTOMER RETURNED A PRODUCT SAMPLE OF ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED IT IN PARALLEL WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE RETENTION SAMPLE MET THE SPECIFICATION FOR POTENCY AD SPECIFICITY, BUT THE PRODUCT SAMPLE PROVIDED BY THE CUSTOMER SHOWED FALSE NEGATIVE RESULTS IN ALL TESTINGS. THE ANTI-IGG-ACTIVITY WAS NO LONGER DETECTABLE IN THE PROVIDED PRODUCT SAMPLE. INSTRUMENT DATA OF THE AFFECTED TANGO INFINITY WERE ANALYZED. ON (B)(6), 2024 THE TEST RESULT WAS POSITIVE AS EXPECTED, ON NOVEMBER 16, 2024, A FALSE NEGATIVE RESULT WAS YIELDED. AFTER LOADING A NEW BOTTLE OF AHG, THE TEST RESULT WITH THE PATIENT SAMPLE WAS POSITIVE AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20923252 ↗
• MalfunctionJun 13, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF HER POSITIVE CONTROL FOR WEAK D AND ANTIBODY SCREENING TESTS. NO PATIENT RESULTS WERE AFFECTED. NO SAMPLES ARE BEING COLLECTED. THE CUSTOMER RETURNED A PRODUCTT SAMPLE OF ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED IT IN PARALLEL WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE RETENTION SAMPLE MET THE SPECIFICATION FOR POTENCY, BUT THE COMPLAINT SAMPLE SHOWED FALSE NEGATIVE RESULTS. OUR TESTING CONFIRMED THE CUSTOMER´S FINDING. THE INVESTIGATION OF THE AFFECTED TANGO INFINITY IS STILL ONGOING. BASED ON THE ONGOING INVESTIGATION WE WERE NOT ABLE TO PROVIDE A CONCLUSIVE STATEMENT. THE RETENTION SAMPLE REACTED AS EXPECTED, BUT THE TESTING OF THE COMPLAINT SAMPLE CONFIRMED CUSTOMER´S FINDING. THE INVESTIGATION 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 19525980 ↗
• MalfunctionDec 21, 2016False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF HER POSITIVE WEAK D CONTROL WITH ANTI-HUMAN-GLOBULIN (AHG), ANTI-IGG SOLIDSCREEN II ON TANGO OPTIMO. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT BUT NOT THE CONTROL THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. AT THE TIME THE COMPLAINT SAMPLE ARRIVED ON OUR PREMISES THE SUPPOSEDLY DEFECTIVE WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THE RETURNED SAMPLE IN PARALLEL TO THEIR RETENTION SAMPLE. THE COMPLAINT SAMPLE SHOWED NO REACTIVITY. ALL REACTIONS WHICH WERE SUPPOSED TO BE POSITIVE WERE FALSE NEGATIVE. THE RETENTION SAMPLE SHOWED CORRECT POSITIVE AND NEGATIVE RESULTS. BOTH, THE COMPLAINT SAMPLE AS WELL AS THE RETENTION SAMPLE, WERE TESTED FOR MICROBIOLOGICAL GROWTH. THE RESULT WAS NO MICROBIOLOGICAL GROWTH. ADDITIONALLY THE COMPLAINT SAMPLE AND THE RETENTION SAMPLE WERE TESTED IN AN EXTERNAL LABORATORY FOR HUMAN SERUM ALBUMIN. THE EXTERNAL LABORATORY COULD DETERMINE HUMAN SERUM ALBUMIN IN THE COMPLAINT SAMPLE, BUT NOT IN THE RETENTION SAMPLE. THE PRESENCE OF HUMAN SERUM ALBUMIN CAN BE A MARKER FOR THE PRESENCE OF HUMAN IMMUNOGLOBULIN G (IGG). AND HUMAN IGG NEUTRALIZES THE ANTI-IGG OF THE AHG AND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6192508 ↗
• MalfunctionAug 24, 2016False Negative Result; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED FALSE NEGATIVE ANTIBODY SCREENING TESTS OF TWO PATIENT SAMPLES WHEN TESTED WITH ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II ON TANGO INFINITY. IN A QC RUN TWO HOURS PRIOR TO THE FALSE NEGATIVE TEST RESULTS, THE VERY SAME AHG BOTTLE THAT LATER YIELDED THE FALSE NEGATIVE TEST RESULTS WAS STILL WORKING CORRECTLY AND YIELDED A POSITIVE RESULT. A REGULAR QUALITY CONTROL RUN ON THE INSTRUMENT THE NEXT DAY (22 HOURS AFTER THE (B)(6)) FAILED. WHEN THE AHG BOTTLE WAS REPLACED, THE QC RUN ON THIS INSTRUMENT PASSED. RE-TESTING OF THE PATIENT SAMPLES SHOWED THAT THE SAMPLES WERE PREVIOUSLY REPORTED TO BE NEGATIVE BUT FOUND TO BE POSITIVE. ONE PATIENT WAS SUPPOSED TO HAVE AN ANTI-JK(A), THE SECOND PATIENT WITH UNKNOWN HISTORY IS STILL INVESTIGATED AT THE CUSTOMER'S SITE. WHILE WAITING FOR AN ACTUAL SAMPLE USED IN THIS FALSE NEGATIVE TESTING, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II WITH DIFFERENT CONTROLS AND SAMPLES. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5899605 ↗
• DeathAug 24, 2016False Negative Result; Defective Component

  THE CUSTOMER REPORTED FALSE NEGATIVE ANTIBODY SCREENING TESTS OF A PATIENT SAMPLE WHEN TESTED WITH ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II ON TANGO INFINITY. IN A QC RUN TWO HOURS PRIOR TO THE FALSE NEGATIVE TEST RESULT , THE VERY SAME AHG BOTTLE THAT LATER YIELDED THE FALSE NEGATIVE TEST RESULT WAS STILL WORKING CORRECTLY AND YIELDED A POSITIVE RESULT. A REGULAR QUALITY CONTROL RUN ON THE INSTRUMENT THE NEXT DAY (22 HOURS AFTER THE FALSE NEGATIVE (B)(6)) FAILED. WHEN THE AHG BOTTLE WAS REPLACED, THE QC RUN ON THIS INSTRUMENT PASSED. RE-TESTING OF THE PATIENT SAMPLE SHOWED THAT THE SAMPLE WAS PREVIOUSLY REPORTED TO BE NEGATIVE BUT FOUND TO BE POSITIVE. THE PATIENT WAS A SICKLE CELL PATIENT WITH A HISTORY OF ANTI-C, ANTI-K, ANTI-KP(A), ANTI-JK(B), ANTI-S AND ANTI-SD(A). WHILE WAITING FOR AN ACTUAL SAMPLE USED IN THIS FALSE NEGATIVE TESTING, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF ANTI-HUMAN-GLOBULIN, ANTI-IGG SOLIDSCREEN II WITH DIFFERENT CONTROLS AND SAMPLES. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE RESULTS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTE

  Patient problems: Death

  MAUDE report 5899602 ↗