IH-Card AHG Anti-IgG 813421100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611969952168), received between Feb 27, 2020 and Feb 1, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED TINY ARTEFACTS AND FREE FLOATING CELLS IN HER RESULTS WITH IH-CARD AHG ANTI-IGG. THE CUSTOMER STATED THAT SHE WAS VALIDATING THE WEAK D TESTING ON HER IH-READER 24. SHE REPORTED THAT THE INSTRUMENT CALLED THE AFFCTED REACTIONS EITHER AS QUESTION MARK OR AS NEGATIVE. SHE REVIEWED THE RESULTS AND FELT THEY SHOULD HAVE BEEN POSITIVE. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED THE INCORRECT RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND THE RETENTION SAMPLE OF THE IH-ANTI-D BLEND LOT THE CUSTOMER HAD USED. TESTING WAS PERFORMED WITH DIFFERENT DONOR SAMPLES USING TWO DIFFERENT IH-READER 24. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NEITHER OBSERVE ANY TINY ARTEFACTS NOR FREE FLOATING CELLS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE ARE STILL WAITING FOR THE INSTRUMENT FILES FROM THE CUSTOMER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257680 ↗
• MalfunctionFeb 1, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED TINY ARTEFACTS AND FREE FLOATING CELLS IN HER RESULTS WITH IH-CARD AHG ANTI-IGG. THE CUSTOMER STATED THAT SHE WAS VALIDATING THE WEAK D TESTING ON HER IH-READER 24. SHE REPORTED THAT THE INSTRUMENT CALLED THE AFFECTED REACTIONS EITHER AS QUESTION MARK OR AS NEGATIVE. SHE REVIEWED THE RESULTS AND FELT THEY SHOULD HAVE BEEN POSITIVE. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED THE INCORRECT RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND THE RETENTION SAMPLE OF THE IH-ANTI-D BLEND LOT THE CUSTOMER HAD USED. TESTING WAS PERFORMED WITH DIFFERENT DONOR SAMPLES USING TWO DIFFERENT IH-READER 24. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NEITHER OBSERVE ANY TINY ARTEFACTS NOR FREE FLOATING CELLS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE ARE STILL WAITING FOR THE INSTRUMENT FILES FROM THE CUSTOMER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257609 ↗
• MalfunctionSep 3, 2020False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE DONOR SAMPLE WITH IH-CARD AHG ANTI-IGG AND IH-CELL I-II-III. THE CUSTOMER PERFORMED THE TEST MANUALLY. HE STATED THAT THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-FYB. THE ANTIBODY WAS DETECTED IN THE SOLID PHASE METHOD AND THE GEL METHOD OF A COMPETITOR. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE IH-CARD AHG ANTI-IGG FOR INVESTIGATIONAL TESTING. OUR QC LABORATORY MANUALLY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT IH-CARD AHG ANTI-IGG USING THE IH-CELL I-II-III LOT 8027011, AS USED AT THE CUSTOMER SITE. THE TESTING WAS PERFORMED WITH IH-INCUBATOR L AS WELL AS IH-CENTRIFUGE L. THE FOLLOWING SAMPLES WERE USED FOR THE ANTIBODY SCREENING TEST: 3 DONOR SAMPLES EXPECTED TO BE NEGATIVE. 3 KNOWN ANTI-FYA (POLYCLONAL). 1 KNOWN ANTI-E (POLYCLONAL). 1 KNOWN ANTI-FYB (POLYCLONAL). ALL NEGATIVE SAMPLES USED REACTED CLEARLY NEGATIVE. THE REACTIONS WITH THE KNOWN ANTIBODIES WERE SPECIFIC. BOTH FYB-ANTIGEN POSITIVE TEST CELLS REACTED WITH A REACTION STRENGTH OF 3+. THE CUSTOMER STATES THAT BOTH HOMOZYGOUS FYB-ANTIGEN POSITIVE TEST CELLS REACTED NEGATIVE AND THE COMPARED TEST CELLS FROM ORTHO REACTED ONLY WITH O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10487681 ↗
• MalfunctionFeb 27, 2020False Negative Result; Defective Device

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A SAMPLE WHEN TESTED WITH IH-CARD AHG ANTI-IGG ON IH-500. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-D. THE CUSTOMER STATED THAT THE SAMPLE WAS WEAK POSITIVE FOR ANTIBODY SCREEN USING ORTHO MANUAL GEL, BUT NEGATIVE USING THE IH-SYSTEM THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT IH-CARD AHG ANTI-IGG FOR INVESTIGATIONAL TESTING, BUT THE SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. TESTING 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; No Known Impact Or Consequence To Patient

  MAUDE report 9762321 ↗