IH-500 001510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611969233786), received between Feb 23, 2022 and May 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 29, 2026False Negative Result

  CUSTOMER REPORTED DISCREPANT ANTIBODY SCREENING RESULTS, WITH SUSPECTED LOW RED BLOOD CELL DISPENSING CAUSING AN INITIALLY WEAK/NEGATIVE REACTION COMPARED WITH REPEAT TESTING. REVIEWED SNAPSHOT DATA, INSTRUMENT TIMELINE, AND CUSTOMER IMAGES FOR SAMPLE (B)(6) ON IH-500 SN (B)(6). INITIAL TEST SHOWED ABNORMALLY LOW RBC PELLET DESPITE CORRECT INSTRUMENT PIPETTING VOLUME. REVIEW CONFIRMED THE SCREENING CELL SUSPENSION USED FOR THE INITIAL TEST WAS NON-COMPLIANT (INSUFFICIENT RBC CONCENTRATION / POOR SUSPENSION). REPEAT TESTING WITH A NEWLY LOADED REAGENT KIT SHOWED NORMAL PELLET FORMATION AND EXPECTED PERFORMANCE. ADDITIONAL IMAGE ANALYSIS WITH R&D CONFIRMED THAT THE REDUCED PELLET IN THE ORIGINAL TEST WAS AT THE THRESHOLD LIMIT OF THE LOW PELLET DETECTION ALGORITHM. SINCE THE PELLET WAS BORDERLINE AND NOT BELOW THE CONFIGURED THRESHOLD, THE LOW PELLET ALARM WAS NOT TRIGGERED. THE LOW PELLET CONTROL IS DESIGNED TO REDUCE RISK OF FALSE NEGATIVE INTERPRETATION, BUT IN THIS CASE THE PELLET REMAINED AT THE DETECTION LIMIT. BASED ON AVAILABLE EVIDENCE, NO INSTRUMENT MALFUNCTION WAS IDENTIFIED; THE DISCREPANT RESULT WAS ATTRIBUTED TO REAGENT HANDLING / NON-COMPLIANT SUSPENSION QUALITY. RESOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331917 ↗
• MalfunctionApr 28, 2026Device Handling Problem

  DURING VALIDATION AFTER INSTALLATION, THE CUSTOMER EXPERIENCED INTERMITTENT ISSUES WITH IH-CELL A1, B REAGENT RECOGNITION (BARCODE UNREADABLE / REAGENT EMPTY DESPITE FULL VIAL). TROUBLESHOOTING CONFIRMED CORRECT REAGENT REFERENCE AND STABLE CONNECTIVITY. A SUBSEQUENT TECHNICAL SUPPORT INVESTIGATION IDENTIFIED INCORRECT REAGENT POSITION MAPPING (POSITIONS 5 AND 6 MAPPED TO THE SAME LOCATION), LEADING TO ASPIRATION ATTEMPTS FROM AN UNLOADED POSITION. A REAGENT AREA TEACHING PROCEDURE CORRECTED THE MAPPING. PROBLEM: THE INSTRUMENT ENCOUNTERED A TARGET OUT OF RANGE ERROR 0X030402 FOR THE PIPETTOR Y AXIS (SEE QN (B)(4)), ACTION: THE FSE ADJUSTED THE POSITIONS TO OVERCOME THIS ERROR. THE FSE DID NOT FOLLOW CORRECTLY THE "IH-500 NI PIPETTOR OBJECT OUT OF RANGE" PROCEDURE (*), COMBINED WITH THE LACK OF THE SOFTWARE SAFETY FEATURE THE WRONG POSITION WAS SAVED. CONSEQUENTLY. POSITION 3 WAS ACCESSED INSTEAD OF POSITION 4. (*) MOST PROBABLY DID NOT DRIVE THE PIPETTOR TO THE CORRESPONDING POSITION IN THE 2ND ROW, BUT A POSITION BESIDE THE AFFECTED POSITION (SEE 6.2.4 IN THE PROCEDURE). TESTING: THE ISSUE WAS DETECTED DURING A CONTROL RUN. AFTER REPLACING THE INSTRUMENT PARAMETER WITH AN OLDER V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019093 ↗
• MalfunctionApr 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED DP REACTIONS BEING CALLED ON B CELL WELLS ON IH-500. INVESTIGATION INCLUDED REVIEW OF DAILY JOURNALS, SCREENSHOTS, AND CUSTOMER WORKFLOW. ALTHOUGH FULL IMAGE ANALYSIS WAS NOT POSSIBLE DUE TO MISSING IMAGES, THE AVAILABLE DATA SHOWED THAT REACTIONS VISUALLY APPEARED AS STRONG POSITIVE (4+) BUT WERE INTERPRETED AS DP BY THE SYSTEM. IT WAS CLARIFIED THAT IN REVERSE GROUPING, SOME NON-REACTIVE CELLS ARE EXPECTED DUE TO POOLED REAGENT RED CELLS, AND THEREFORE THESE REACTIONS DO NOT REPRESENT TRUE DP REACTIONS. IN ADDITION, THE CURRENT SOFTWARE VERSION HAS A KNOWN LIMITATION IN DP DETECTION, WHICH MAY LEAD TO OVERCALLING IN SUCH CASES. THE BEHAVIOR MAY ALSO BE INFLUENCED BY CENTRIFUGE TEACHING AND CARD HOLDER POSITIONING. RECOMMENDATIONS WERE PROVIDED, INCLUDING CENTRIFUGE TEACHING, MECHANICAL CHECKS, AND UPGRADE TO SOFTWARE VERSION 3.1, WHICH INCLUDES IMPROVED DP INTERPRETATION. RESOLUTION: CUSTOMER WAS ADVISED TO PERFORM CENTRIFUGE TEACHING, CHECK CARD HOLDER POSITIONING, AND PROCEED WITH SOFTWARE UPGRADE TO V3.1. CUSTOMER CONFIRMED NO FURTHER SUPPORT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24992013 ↗
• MalfunctionFeb 23, 2022False Positive Result; Output Problem; False Positive Result; Output Problem

  THE CUSTOMER PROCESSED A PATIENT SAMPLE WITH IH-CARD ABO/D(DVI-)+REV. A1, B ON IH-500.THE CUSTOMER REPORTED THAT A DP (DOUBLE POPULATION, MIXED FIELD) REACTION WAS NOT RECOGNIZED AS SUCH BUT WAS EVALUATED AS A 2+ POSITIVE REACTION BY THE INSTRUMENT. THE CUSTOMER DID NEITHER PROVIDE THE ALLEGEDLY DEFECTIVE PRODUCT SAMPLE IH-CARD ABO/D(DVI-)+REV. A1, B FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED "THEIT" RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DONOR SAMPLES ON IH-500. VARIOUS WEAK D RED BLOOD CELL SAMPLES WERE ALSO PART OF THE TESTS. 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. AN INVESTIGATION OF THE AFFECTED IH-500 DATA IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583550 ↗