Anti-Human-Globulin, Anti-IgG 804175100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969950706), received between Sep 21, 2022 and Sep 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED DISCREPANT DAT RESULTS BETWEEN VISUAL AND INSTRUMENTS SOFTWARE INTERPRETATION AND FURTHER ALSO BETWEEN (B)(4) TANGO INFINITY INSTRUMENTS AND THE MANUAL TUBE TECHNIQUE. THE CUSTOMER RETURNED THE AHG ANTI-IGG WHICH WAS USED IN THE DIRECT ANTIGLOBULIN TEST (DAT) IN THE TUBE TECHNIQUE FOR INVESTIGATIONAL TESTING AND ALSO ONE PATIENT SAMPLE. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE FOR POTENCY AND SPECIFICITY. THE TESTING WAS DONE IN PARALLEL WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND A REFERENCE LOT. ALL THREE REAGENTS SHOWED COMPARABLE RESULTS AND THE ACCEPTANCE CRITERIA WERE MET. ADDITIONALLY OURNQUALITY CONTROL LABORATORY TESTED THE AHG ANTI-IGG SOLIDSCREEN II THE CUSTOMER SENT IN FOR POTENCY AND SPECIFICITY. THE TESTING WAS DONE IN PARALLEL WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND A REFERENCE LOT. ALL THREE REAGENTS SHOWED COMPARABLE RESULTS AND THE ACCEPTANCE CRITERIA WERE MET. THE PATIENT SAMPLE WAS TESTED ON TANGO INFINITY: DAT AND ANTIBODY SCREENING TEST WITH BIOTESTCELL (B)(4) INCLUSIVE AUTO CONTROL WERE CLEARLY NEGATIVE. IT WAS ALSO TESTED ON THE · IH-CARD AHG ANTI-IGG, -C3D AND THE DAT WAS NEGATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460615 ↗
• MalfunctionSep 21, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED DISCREPANT DAT RESULTS BETWEEN VISUAL AND INSTRUMENTS SOFTWARE INTERPRETATION AND FURTHER ALSO BETWEEN TWO TANGO INFINITY INSTRUMENTS AND THE MANUAL TUBE TECHNIQUE. THE CUSTOMER RETURNED THE AHG ANTI-IGG WHICH WAS USED IN THE DIRECT ANTIGLOBULIN TEST (DAT) IN THE TUBE TECHNIQUE FOR INVESTIGATIONAL TESTING AND ALSO ONE PATIENT SAMPLE. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE FOR POTENCY AND SPECIFICITY. THE TESTING WAS DONE IN PARALLEL WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND A REFERENCE LOT. ALL THREE REAGENTS SHOWED COMPARABLE RESULTS AND THE ACCEPTANCE CRITERIA WERE MET. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THE AHG ANTI-IGG SOLIDSCREEN II THE CUSTOMER SENT IN FOR POTENCY AND SPECIFICITY. THE TESTING WAS DONE IN PARALLEL WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND A REFERENCE LOT. ALL THREE REAGENTS SHOWED COMPARABLE RESULTS AND THE ACCEPTANCE CRITERIA WERE MET. THE PATIENT SAMPLE WAS TESTED ON TANGO INFINITY: DAT AND ANTIBODY SCREENING TEST WITH BIOTESTCELL 3 INCLUSIVE AUTO CONTROL WERE CLEARLY NEGATIVE. IT WAS ALSO TESTED ON THE IH-CARD AHG ANTI-IGG, C3D AND THE DAT WAS NEGATIVE. FURTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460614 ↗