IH-Com V5.0 5.0.10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07611969234417), received between Sep 25, 2019 and Dec 10, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED THAT THE IH-COM OF THEIR IH-1000 INSTRUMENT AUTO-VERIFIED A PATIENT BLOOD TYPE AS A POSITIVE AND SUSPECTED A POTENTIALLY MISSED DOUBLE POPULATION (DP) REACTION. THE INITIAL TEST WAS PERFORMED ON THE IH-1000, AND IH-COM AUTO-VERIFIED THE BLOOD TYPE WITHOUT FLAGGING ANY DISCREPANCIES. PER LAB POLICY, A SECOND SAMPLE WAS REQUIRED FOR CONFIRMATION USING THE TUBE METHOD. DURING THIS SECOND TEST, THE TECHNICIAN IDENTIFIED A NEGATIVE IN A RECENTLY TRANSFUSED PATIENT. THE DAILY JOURNAL WAS REVIEWED BY ONE OF OUR FIELD SERVICE ENGINEERS AND IT WAS CONFIRMED THAT IH-COM AUTO-VALIDATED THE RESULT BECAUSE THE DIRECT AND REVERSE GROUPING WERE CONSISTENT. INITIAL INTERPRETATION FOLLOWED EXPECTED LOGIC PER THE GEL CARD IFU. IH-1000 TRACE FILES, AND ORIGINAL IMAGES FROM (B)(6) 2025 WERE REVIEWED. OUR R&D DEPARTMENT ANALYZED THE ORIGINAL GEL IMAGE USING THE VALIDATED IH SCANGEL ALGORITHM. THE DETECTED PELLET VALUE WAS 9, BELOW THE VALIDATED DP THRESHOLD OF 14. CAMERA CALIBRATION WAS ALSO CONSIDERED AND EXCLUDED AS A CONTRIBUTING FACTOR. THE RESULT WAS CORRECTLY INTERPRETED AS POSITIVE PER VALIDATED ALGORITHM LOGIC. NO SOFTWARE, ALGORITHM, OR CALIBRATION ISSUE WAS IDENTIFIED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23765452 ↗
• MalfunctionApr 25, 2025Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT AN INCORRECT TEST RESULT WAS RELEASED BY IH-COM TO THE LIS. THE SAMPLE WAS A POS IN IH-COM AND RELEASED TO THE LIS AS A A POSITIVE BUT WAS B POS. BECAUSE THE RH WAS STILL PENDING, NO INCORRECT TEST RESULT WAS COMMUNICATED AND NO PATIENT WAS HARMED. TRACE FILES WERE COLLECTED BY ONE OF OUR FIELD SERVICE ENGINEERS AND ARE STILL UNDER INVESTIGATION. OUR PREMILARY INVESTIGATION SHOWS THAT THE INCORRECT BLOOD GROUP INTERPRETATION STORED IN THE IH-COM IS DUE TO A MANUAL CHANGE TO THE ABO INTERPRETATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906959 ↗
• MalfunctionDec 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT TWO TEST RESULTS OBTAINED ON THEIR (B)(6) INSTRUMENT WERE TRANSMITTED PREMATURELY TO THE CUSTOMER'S LIS SYSTEM WITHOUT BEING APPROVED BY THE TECHNICIAN. THE RESULTS NEEDED TO BE EDITED ON THE INSTRUMENT PRIOR TO BEING APPROVED. A FULL IH-COM DATABASE BACKUP WAS REQUESTED BUT THE UPLOAD TO THE TRANSFER SITE. FAILED. THEREFORE, AN INVESTIGATION OF THE DATABASE BACKUP WAS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20936346 ↗
• MalfunctionJun 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ONE TEST RESULT WAS LINKED TO THE WRONG PATIENT DEMOGRAPHICS BY IH-COM ON THE IH-1000 INSTRUMENT. A PATIENT ASSIGNED WITH ACCESSION NUMBER (B)(6) WAS PROCESSED AND TESTED ON (B)(6) 2023. THE BLOOD GROUP WAS AB RH TYPE POS. THE PATIENT'S PHYSICIAN CONTACTED THE CUSTOMER TO INFORM THEM THE REPORT INDICATED A BLOOD GROUP OF O AND RH TYPE POS. A CORRECTED REPORT WAS PROVIDED TO THE PATIENT'S PHYSICIAN. WHEN SEARCHING THE RESULTS IN IH-COM, THE CUSTOMER NOTICED THAT THERE WAS ANOTHER SAMPLE FROM ANOTHER PATIENT WITH THE SAME ACCESSION NUMBER THAT WAS TESTED ON (B)(6) 2022. THE RESULT OF THIS TESTING WAS BLOOD GROUP O AND RH TYPE POS. FOR THE PATIENT TESTED ON (B)(6) 2023, THERE WAS A DISCREPANT BLOOD GROUP REPORTED FROM THE SITE, BUT THE CORRECT RESULT WAS STILL AVAILABLE IN IH-COM V5.0. IMAGES WERE COLLECTED AND THE AUDIT TRAILS WERE CHECKED. THERE WAS NO RECORD OF THE GROUP OR TYPE BEING EDITED, HOWEVER THE ABS WAS EDITED FOR THE SAMPLE THAT WAS TESTED ON (B)(6) 2023. THERE WAS NO AUDIT TRAIL AVAILABLE ANY MORE FOR THE SAMPLE TESTED ON (B)(6) 2022. THE CUSTOMER STATED THAT NONE OF THE STAFF COULD REMEMBER THE SAMPLE FROM (B)(6) 2023 NEEDING ANY MANUAL TESTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465891 ↗
• MalfunctionFeb 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A WRONG RESULT WAS LINKED TO THE WRONG PATIENT DEMOGRAPHICS ON IH-COM ON THE IH-1000 INSTRUMENT. DATAFILES OF THE AFFECTED IH-1000 WERE RETRIEVED BY ONE OF OUR FIELD SERVICE ENGINEERS AND INVESTIGATED. THE PRELIMINARY INVESTIGATION SHOWS THE MISMATCH IS LINKED TO A USER ACTION, WHERE USER PATIENT CXXXXXX, MXXXXXX MRN (B)(6) WAS MERGED WITH GXXXXX, MXXX MRN (B)(6). THIS WAS DONE ON JANUARY 9TH AT 03:09. AFTER THE FIRST CHANGE OF PATIENT DEMOGRAPHICS WAS DONE, THE SAME USER PERFORMED SEVERAL CHANGES ON THIS SAMPLE ID. EVIDENCE WAS FOUND IN THE IH-COM SYSTEM LOG. ONCE THE PATIENT FILES WERE MERGED, THE FOLLOWING SAMPLES WERE LINKED TO THE DEMOGRAPHICS OF PATIENT CXXXXXX, MXXXXXX (MRN (B)(6)), SAMPLES WERE MANUALLY CONFIRMED BY THE CUSTOMER AS CORRECT FOR THIS PATIENT. FOR PATIENT GXXXXX, MXXX MRN (B)(6), THE PATIENT HISTORY ONLY INCLUDES 1 SAMPLE, THAT WAS PROCESSED AFTER THE MERGING EVENT. THE RESULTS PRIOR TO THIS EVENT ARE NOW INCLUDED IN PATIENTS' CXXXXXX, MXXXXXX FILE. IN INVESTIGATING THE INCIDENT INVOLVING IH-COM SENDING THE WRONG RESULT TO THE WRONG PATIENT, A DETAILED ANALYSIS OF THE DATABASE PROVIDED DURING THE CASE ESCALATION WAS CONDUCTED, SPECIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648106 ↗
• MalfunctionNov 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT IH-COM ON THE IH-1000 INSTRUMENT ASSIGNED AN INCORRECT TEST RESULT TO A PATIENT. ONE SAMPLE (NO. (B)(6)) WAS PROCESSED ON THE IH-1000 INSTRUMENT ON (B)(6) 2018 ON ONE PATIENT. THE SAME SAMPLE NUMBER (B)(6) WAS REUSED ON (B)(6) 2022 FOR A DIFFERENT PATIENT. THE PATIENT DATA ARE PROPERLY MANAGED AND ASSIGNED. IN IH-COM, SAMPLES ARE HANDLED FULLY SEPARATELY AS VISIBLE ON THE PRINTSCREENS THAT WERE PROVIDED FOR INVESTIGATION. IH-COM CONSEQUENTLY COULD NOT SENT THE WRONG RESULTS TO THE LIS WITH AN AUTOMATIC RESULT SENDING TO LIS AFTER RESULT VALIDATION. VISIBLE IN THE SUPPORT BACKUP IS THAT A USER SENDS RESULTS MANUALLY TO THE LIS AND SENDS TWO RESULTS OF THE SAME SAMPLE NUMBER. IN THE LIS DATA, SAMPLE AND PATIENT DATA ARE ALWAYS VISIBLE BUT HERE, LIS CONSIDERED ONLY THE SAMPLE NUMBER AND NOT THE PATIENT DATA CAUSING A MIX-UP IN THE LIS. BY REVIEWING THE LIS FILES, IN FACT THE USER SENT TWICE THE RESULTS OF SAMPLE (B)(6) FOR THE SAMPLE PROCESSED IN 2018. IH-COM SENT PROPERLY THE DATA ASSOCIATED WITH THE PATIENT DATA FROM 2018. THE ROOT CAUSE OF THE REPORTED ISSUE HAS A COMBINATION OF TWO ISSUES: HANDLING ISSUE: USER SENT MANUALLY TO THE LIS THE RESULTS FROM 20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713758 ↗
• MalfunctionJul 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT IH-COM ON THE IH-1000 INSTRUMENT ASSIGNED AN INCORRECT TEST RESULT TO A PATIENT. IN IH-COM, THE FIRST 2 DIGITS OF THE CUSTOMER NUMBER IS FOR THE YEAR (I.E., 21=2021; 22=2022, ETC.). THE CUSTOMER ERRONEOUSLY SELECTED A PATIENT FROM ON (B)(6) 2021 INSTEAD OF ON (B)(6)2022 (SAME ID NUMBER EXCEPT FOR THE "22" IN FRONT OF THE NUMBER), AND THE ORIGINAL IMAGE WELL RESULTS WERE STILL PRESENT. THE RESULT WAS RELEASED BEFORE IT WAS NOTICED, AND THE ACTUAL PATIENT ON (B)(6) 2022 WAS A DIFFERENT BLOOD TYPE. THE CUSTOMER HAD TO PROCESS A CORRECTED REPORT. THE CUSTOMER WAS QUESTIONING WHEN THE ORIGINAL IMAGES DISAPPEAR AND ARE REPLACED BY A "RENDERING" OR A PICTURE REPRESENTATION. IH-COM DATA FILES WERE RECEIVED FOR INVESTIGAION BUT WERE CORRUPT. FOR THIS REASON, WE COULDN'T YET ANALYZE THE CUSTOMER SPECIFIC DATA BASE YET. BUT GENERALLY IN IH-COM ONE HAS THE POSSIBILITY TO "REOPEN VERIFIED OR VALIDATED TESTS". THIS IS ONLY POSSIBLE BY A USER WITH THE RIGHTS 90 OR HIGHER (IH-COM ADMINISTRATORS). THE OPTION "RESEND" WILL SEND A RESULT AGAIN TO THE HOST/LIS. THIS MAY LEAD TO AN ISSUE AS THE LIS THE CUSTOMER IS USING IS NOT TAKING THE FIRST TWO DIGITS OF THE SAMPLE BARCODE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15091570 ↗
• MalfunctionJul 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT IH-COM ON THE IH-1000 INSTRUMENT ASSIGNED AN INCORRECT TEST RESULT TO A PATIENT. IN IH-COM, THE FIRST 2 DIGITS OF THE CUSTOMER NUMBER IS FOR THE YEAR (I.E., 21=2021; 22=2022, ETC.). THE CUSTOMER ERRONEOUSLY SELECTED A PATIENT FROM (B)(6) 2021 INSTEAD OF (B)(6) 2022 (SAME ID NUMBER EXCEPT FOR THE "22" IN FRONT OF THE NUMBER), AND THE ORIGINAL IMAGE WELL RESULTS WERE STILL PRESENT. THE RESULT WAS RELEASED BEFORE IT WAS NOTICED, AND THE ACTUAL PATIENT ((B)(6) 2022) WAS A DIFFERENT BLOOD TYPE. THE CUSTOMER HAD TO PROCESS A CORRECTED REPORT. THE CUSTOMER WAS QUESTIONING WHEN THE ORIGINAL IMAGES DISAPPEAR AND ARE REPLACED BY A "RENDERING" OR A PICTURE REPRESENTATION. IH-COM DATA FILES WERE RECEIVED FOR INVESTIGATION BUT WERE CORRUPT. FOR THIS REASON, WE COULDN'T YET ANALYZE THE CUSTOMER SPECIFIC DATA BASE YET. BUT GENERALLY IN IH-COM ONE HAS THE POSSIBILITY TO "REOPEN VERIFIED OR VALIDATED TESTS". THIS IS ONLY POSSIBLE BY A USER WITH THE RIGHTS 90 OR HIGHER (IH-COM ADMINISTRATORS). THE OPTION "RESEND" WILL SEND A RESULT AGAIN TO THE HOST/LIS. THIS MAY LEAD TO AN ISSUE AS THE LIS THE CUSTOMER IS USING IS NOT TAKING THE FIRST TWO DIGITS OF THE SAMPLE BARCODE INTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15091568 ↗
• MalfunctionMay 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS FROM TESTING VS. REPORTED. THE TYPING RESULTS ON THE IH-1000 WERE AUTOMATICALLY ACCEPTED AS "A1B" RH POSITIVE WHEN THE VISUAL ASSESSMENT DEMONSTRATED B RH POSITIVE RESULTS. THE CUSTOMER HANDED IN THE DATA FILES OF THE INSTRUMENT. THE INVESTIGATION OF THE FILES IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884491 ↗
• MalfunctionSep 25, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ATYPICAL RESULTS OF ONE PATIENT. THE CUSTOMER PROVIDED TWO DAILY JOURNAL IMAGES OF TYPE AND SCREEN USING IH-1000 ON THE SAME PATIENT. TWO SAMPLES WERE COLLECTED APPROXIMATELY A WEEK APART WITH SIMILAR RESULTS. THE BACK TYPE AND THE ANTIBODY SCREEN REACTIONS WERE CLEARLY ATYPICAL. THE SOFTWARE IH-COM, VERSION 5.0 INTERPRETED THESE RESULTS AS NEGATIVE, AND THERE ARE VERY CLEARLY NOT NEGATIVE, BUT ALTHOUGH CLEARLY NOT TYPICAL POSITIVE EITHER. IN BOTH CASES THE ABO/RH WAS NTD (NOT TO DETERMINE) DUE TO FORWARD REVERSE MISMATCH. THE RESULTS WERE CORRECTED BY THE USER BUT THE RESULTS WERE FLAGGED NOT FOR THE REASON THEY SHOULD HAVE BEEN. THE PATIENT HAS A HISTORY OF MULTIPLE MYELOMA AND THE EXAMPLES WERE EXPECTED TO PRESENT WITH ATYPICAL RESULTS. OUR INVESTIGATION CONFIRMED THAT ALL TESTS WERE CORRECTLY PERFORMED BY THE INSTRUMENT AND NO ISSUE OR MALFUNCTION ON THE INSTRUMENT WAS IDENTIFIED (FROM THE TRACE FILES ANALYSES) AND THE WELLS A1 AND B WERE INTERPRETED AS NEGATIVE. ACCORDING TO THE ANALYSIS OUR TECHNICIAN CONDUCTED THE DETECTION OF THE DOUBLE POPULATION ON THE REVERSE GROUP AND THE AB SCREENING TEST WAS DEACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9115079 ↗