IH-Panel 11 Papain 814080100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969952304), received between Mar 22, 2019 and Mar 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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.

• MalfunctionMar 28, 2025Output Problem; Output Problem

  THE CUSTOMER WANTED TO LOAD IH-PANEL 11 PAPAIN ON HIS IH-500 AND NOTICED IN CELLS 7 AND 2 SMALL CLUMPS OR THREADS. THEREFORE, NO TESTING COULD BE PERFORMED AND THE CUSTOMER SUSPECTED A POSSIBLE CONTAMINATION. THE CUSTOMER SENT IN THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. ALL VIALS PROVIDED BY THE CUSTOMER WERE LEAKED OUT AS NO DROP PIPETTES WERE USED FOR SEALING OF THE OPENED VIALS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE AFFECTED LOT. THE CELLS WERE RESUSPEND AND IT WAS INVESTIGATED IF A PROPER RE-SUSPENSION IS GIVEN OR IF STRANDS OF CELLS ARE VISIBLE. AFTERWARDS THE FILLING VOLUME ON THE IH-500 WAS MEASURED. THE RETENTION SAMPLE WAS ALSO VISUALLY INSPECTED. WHEN CAREFULLY MIXED, NO SMALL CLUMPS OR THREADS WERE VISIBLE. THE SUSPENSIONS WERE WITHOUT ABNORMALITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717927 ↗
• MalfunctionMar 22, 2019False Negative Result

  THE CUSTOMER REPORTED THAT THEY RAN THE IH-PANEL 11 PAPAIN IN PARALLEL TO THE UNTREATED PANEL (IH-PANEL 11) FOR THE SAME LOT OF REAGENTS. THE K+ CELL (#8) ON THE UNTREATED PANEL WAS TESTED AS 1+ AND THE SAME K+ CELL (CELL 8) ON THE IH-PANEL 11 PAPAIN YIELDED A NEGATIVE REACTION. THE RETENTION SAMPLE OF THE ALLEGEDLY DEFECTIVE LOF OF IH-PANEL 11 PAPAIN WAS TESTED WITHIN ITS SHELF LIFE IN OUR QUALITY CONTROL LABORATORY WITH AN ANTI-K AND THE RESULTS WERE AS EXPECTED CORRECT. THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE REACTION WAS REQUESTED FOR INVESTIGATIONAL TESTING BUT HAS SO FAR NOT BEEN PROVIDED. TESTING IN OUR QUALITY CONTROL LABORATORY WILL BE RESUMED WITH TESTING OF THE PATIENT SAMPLE WITH THE CURRENT LOT OF IH-PANEL 11 PAPAIN AS SOON AS WE RECEIVE THE PATIENT SAMPLE. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF IH-PANEL -I11 PAPAIN HAS DURING ITS SHELF LIFE FUNCTIONED 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 Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8443421 ↗