IH-Panel Plus 6 814090100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611969952311), received between Aug 2, 2022 and Sep 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE ANTIBODY IDENTIFICATION ON THE IH-500 INSTRUMENT WITH IH PANEL PLUS 6 WAS INTERPRETED BY THE CUSTOMER AS A NOT PERFECTLY MATCHING ANTI-M. THE SAMPLE WAS SENT TO THE AMERICAN RED CROSS FOR CONFIRMATION OF THIS RESULT AND THERE AN ANTI-FYA WAS IDENTIFIED. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING BUT HE PROVIDED A PATIENT SAMPLE. THIS PATIENT SAMPLE COULD NOT BE TESTED AS IT WAS COMPLETELY HEMOLYZED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DONOR SAMPLES AND FOUR KNOWN ANTIBODIES (2 X ANTI-FYA AND 2 X ANTI-M) ON THE IH-500. ALL RESULTS WERE CORRECT AND WERE ALSO INTERPRETED CORRECTLY BY THE SOFTWARE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE DATA FILES OF THE AFFECTED IH-500 INSTRUMENT WERE ANALYZED. A WELL MISREADING WAS EXCLUDED. ADDING, THE CHECKING OF THE AIRGAP IMAGES COULD DEDUCE THAT ALL TESTS WERE CORRECTLY PERFORMED. THE CELLS AND THE SERUM MIX ON EACH WELL WAS HOMOGENOUS. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS UND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416382 ↗
• MalfunctionAug 2, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH IH-PANEL PLUS 6 ON IH-1000. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-K. CELL #14 OF IH-PANEL PLUS 6 WAS K ANTIGEN POSITIVE AND THEREFORE SUPPOSED TO YIELD A POSITIVE REACTION. THE CUSTOMER STATED THE ANTIBODY WAS DETECTED IN THE MANUAL METHOD. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE IH- PANEL PLUS 6 FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE TEST RESULT. BUT SHE ANNOUNCED TO SHIP THE PATIENT SAMPLE. IN THE MEANTIME, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE TESTING WAS PERFORMED USING IH-CARD AHG ANTI-IGG LOT #9203030, THE SAME LOT CUSTOMER HAD USED. THREE DIFFERENT ANTI-K WERE USED FOR THE TEST AS WELL AS AN ANTI-FYA, ANTI-S AND DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ALL ANTIBODIES WERE CORRECTLY DETECTED. ADDITIONALLY, THE ANTIGEN K HETEROZYGOUS POSITIVE CELL OF IH-PANEL PLUS 6 (CELL #14) WAS TESTED FOR POTENCY IN PARALLEL WITH TWO OTHER ANTIGEN K HETEROZYGOUS REAGENT RED BLOOD CELLS (RRBC) AND ONE ANTIGEN K HOMOZYGOUS RRBC. THIS TESTING WAS DONE MANUALLY. ALL K ANTIGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146133 ↗
• MalfunctionAug 2, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH IH-CELL I-II ON IH-1000. THE SPECIFICITIES OF THE MISSED ANTIBODIES WERE ANTI-K AND ANTI-LEA. CELL #2 OF IH-CELL I-II WAS K AND LEA ANTIGEN POSITIVE AND THEREFORE SUPPOSED TO REACT POSITIVELY. THE CUSTOMER STATED THE ANTIBODIES WERE DETECTED IN THE MANUAL METHOD. THE ANTI-LEA ALSO SHOWED A POSITIVE REACTION IN THE REPEAT TESTING. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE IH- CELL I-II FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE TEST RESULT. BUT SHE ANNOUNCED TO SHIP THE PATIENT SAMPLE FOR INVESTIGATION. IN THE MEANTIME, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. THE TESTING WAS PERFORMED USING IH-CARD AHG ANTI-IGG LOT #9203030, THE SAME LOT CUSTOMER HAD USED. THREE DIFFERENT ANTI-K, THREE DIFFERENT ANTI-LEA WERE USED FOR THE TEST AS WELL AS AN ANTI-FYA, ANTI-S AND DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ALL ANTIBODIES WERE CORRECTLY DETECTED. ADDITIONALLY, THE ANTIGEN K HETEROZYGOUS POSITIVE CELL OF IH-CELL I-II (CELL #2) WAS TESTED FOR POTENCY IN PARALLEL WITH THREE OTHER K ANTIGEN HET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145595 ↗