IH-Cell I-II 814050100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07611969952274), received between Jan 7, 2020 and Sep 8, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A NEGATIVE RESULT WITH OUR PRODUCT IH-CELL I-II FOR TWO TESTS OF THE SAME PATIENT. ONE TEST WAS PERFORMED ON (B)(6) 2023 AND THE SECOND TEST WAS PERFOMRED ON (B)(6) 2025 AND THE TEST RESULTS WERE NEGATIVE EACH TIME. ANOTHER FACILITY DETECTED AN ANTI-C . THE PATIENT HAD NO KNOWN TRANSFUSION HISTORY. THE CUSTOMER REPORTED BOTH CASES ON AUGUST 11, 2025. WHILE HE WAS ABLE TO PROVIDE INFORMATION ON THE PRODUCT USED FOR THE TEST PERFORMED IN (B)(6) 2025, HE WAS NOT ABLE TO PROVIDE SUCH INFORMATION ON THE PRODUCT USED IN THE TEST BACK IN 2023. ALSO, IT WAS NOT POSSIBLE TO RETRIEVE DATA FROM THE IH-1000 USED FOR TESTING. FOR THIS REASON, WE REFRAIN FROM SUBMITTING A REPORT FOR THE INCIDENT IN (B)(6) 2023. REGARDING THE ALLEGEDLY FALSE NEGATIVE TEST RESULT OBTAINED IN (B)(6) 2025, THE CUSTOMER DID NOT PROVIDE A PATIENT SAMPLE FOR INVESTIGATIONAL TESTING IN OUR QUALITY CONTROL LABORATORY. THE CUSTOMER FILED HIS COMPLAINT IN AUGUST 2025, WHEN THE ALLEGEDLY DEFECTIVE LOT OF IH-CELL I-II HAS ALREDAY BEEN EXPIRED SIX WEEKS AGO, THEREFORE, NO TESTS COULD BE CARRIED OUT. A REVIEW OF OUR BATCH RECORD HAS NOT SHOWN ANY ABNORMALITIES THAT COULD HAVE NEGATIVELY AFFECTED PRODUCT Q

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22990137 ↗
• MalfunctionOct 9, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF ONE PATIENT SAMPLE WITH THE ANTI-B OF ERYTYPE S ABD+REV. A1, B ON TANGO INFINITY. THE REVERSE TYPING AND THE RH(D) DETERMINATION OF THE PATIENT SAMPLE WERE CORRECT. THE PREVIOUS HISTORY FOR THE PATIENT WAS BLOOD GROUP A RH(D) POSITIVE. THE CUSTOMER STATED THAT THE PATIENT SAMPLE WAS RETESTED ON THEIR SECOND TANGO INFINITY S/N (B)(6) AND TYPED CORRECTLY AS BLOOD GROUP A RH(D) POSITIVE. THE PATIENT SAMPLE WAS RETESTED IN THE TUBE TEST AND TYPED AS A RH(D) POSITIVE. FURTHERMORE, THE CUSTOMER RETESTED THE PATIENT SAMPLE ON TANGO INFINITY (B)(6), THE INSTRUMENT WHICH YIELDED THE FALSE POSITIVE REACTION. THE SAMPLE WAS CORRECTLY TYPED AS BLOOD GROUP A RH(D) POSITIVE. DUE TO THE DISCREPANCY BETWEEN THE FORWARD TESTING AND THE REVERSE TYPING OF THE PATIENT SAMPLE IN QUESTION THE TANGO INFINITY DID NOT GENERATE A BLOOD GROUP RESULT. THEREFORE, NO INCORRECT BLOOD GROUP RESULT WAS RELEASED TO THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THT HAD CAUSED THE FALSE POSITIVE TEST RESULT. BUT THE CUSTOMER PROVIDED THEIR SCREENSHOTS OF THE TANGO INF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17893874 ↗
• MalfunctionOct 31, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT A POSITIVE REACTION WAS ASSESSED AS NEGATIVE BY THE IH-READER 24. THE AFFECTED PRODUCT WAS IH-CELL I-II. THE CUSTOMER INFORMED US THAT THE POSITIVE REACTION WAS CAUSED BY A NONSPECIFIC IGG ANTIBODY. THE CUSTOMER DID NOT PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-CELL I-II FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON THE IH-READER 24. FOUR DIFFERENT WEAK POSITIVE REACTING ANTIBODIES WERE USED FOR THIS TEST: ANTI-D, ANTI-C, ANTI-FYA AND ANTI-K. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ALL REACTIONS WERE CORRECTLY EVALUATED BY THE IH-READER 24. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE COSTUMER SENT IN PATIENT SAMPLES FOR INVESTIGATIONAL TESTING. UPON ARRIVAL, OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLES WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND ALSO THE CURRENT LOT. WITH BOTH LOTS, THE PATIENT SAMPLES REACTED CLEARLY NEGATIVE. THE CONTROLS REACTED CORRECTLY POSITIVE AND NEGATIVE. ALL POSITIVE AND NEGATIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698124 ↗
• 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 15145594 ↗
• 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 15145593 ↗
• 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 SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-E. CELL #2 OF IH-CELL I-II WAS E ANTIGEN POSITIVE AND THEREFORE SUPPOSED TO REACT POSITIVELY. THE CUSTOMER STATED THE ANTIBODY WAS DETECTED IN THE MANUAL METHOD. 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 A 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-E 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 E POSITIVE CELL OF IH-CELL I-II (CELL #2) WAS TESTED FOR POTENCY IN PARALLEL WITH TWO OTHER ANTIGEN E HOMOZYGOUS REAGENT RED BLOOD CELLS (RRBC) AND ONE ANTIGEN E HETEROZYGOUS RRBC. THIS TESTING WAS DONE MANUALLY. ALL E ANTIGEN HOMOZYGOUS RRBS YIELDED THE SAME TITE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145094 ↗
• MalfunctionMay 16, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH CELL #1 OF IH-CELL I-II. THE CUSTOMER STATED THAT THE PATIENT SAMPLE WAS PREVIOUSLY FROZEN AND WAS THAWED FOR A VALIDATION STUDY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-C (RH2). THE CUSTOMER TESTED MANUALLY AND ALSO USED THE IH-READER 24. FURTHERMORE, THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED 1+ POSITIVE REACTIONS WITH IH-PANEL 11 AND THE REAGENT RED BLOOD CELLS (RRBCS) FROM ORTHO. THE CUSTOMER DID NEITHER PROVIDE A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE REACTION. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT LOT. IT WAS TESTED MANUALLY WITH FOUR DIFFERENT ANTI-C (RH2) AND TWO DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ADDITIONALLY, CELL #1 OF IH-CELL I-II WAS TESTED FOR POTENCY. THE TESTING WAS DONE IN PARALLEL WITH THE C-ANTIGEN POSITIVE RRBCS #1, #3 AND #5 OF IH-PANEL 11 AND RRBC #1 OF THE CURRENT LOT IH-CELL I-II. ALL REAGENT RED BLOOD CELLS SHOWED COMPARABLE RESULTS. WE DID NOT OBSERVE ANY WEAKENING OF THE C (RH2) ANTIGEN OF THE AFFECTED RRBC #1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14406067 ↗
• MalfunctionMay 16, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH CELL #1 OF IH-CELL I-II. THE CUSTOMER STATED THAT THE PATIENT SAMPLE WAS PREVIOUSLY FROZEN AND WAS THAWED FOR A VALIDATION STUDY. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-C (RH2). THE CUSTOMER TESTED MANUALLY AND ALSO USED THE IH-READER 24. FURTHERMORE, THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED 1+ POSITIVE REACTIONS WITH IH-PANEL 11 AND THE REAGENT RED BLOOD CELLS (RRBCS) FROM ORTHO. THE CUSTOMER DID NEITHER PROVIDE A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE REACTION. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT LOT. IT WAS TESTED MANUALLY WITH FOUR DIFFERENT ANTI-C (RH2) AND TWO DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ADDITIONALLY, CELL #1 OF IH-CELL I-II WAS TESTED FOR POTENCY. THE TESTING WAS DONE IN PARALLEL WITH THE C-ANTIGEN POSITIVE RRBCS #1, #3 AND #5 OF IH-PANEL 11 AND RRBC #1 OF THE CURRENT LOT IH-CELL I-II. ALL REAGENT RED BLOOD CELLS SHOWED COMPARABLE RESULTS. WE DID NOT OBSERVE ANY WEAKENING OF THE C (RH2) ANTIGEN OF THE AFFECTED RRBC #1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14406065 ↗
• MalfunctionApr 27, 2020False Negative Result; Defective Component

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF AN ANTI-JK(B) WHEN TESTED WITH IH-CELL I-II. THE ANTI-JK(B) WAS DETECTED IN THE ORTHO SYSTEM. THE CUSTOMER STATED THAT THE SAMPLE DERIVED FROM A KNOWN ANTI-JKB PATIENT WAS FROZEN AND USED FOR A PARALLEL STUDY USING ORTHO AND IH-READER 24. THE SAMPLE YIELDED A WEAK 1+ IN ORTHO 3 CELL SCREEN AND A NEGATIVE REACTION WITH IH-CELL-I-II. THE CUSTOMER PROVIDED THE DAILY JOURNAL OF THE IH-READER 24: SAMPLE (B)(6) WAS TESTED IN DUPLICATE USING IH-CARD AHG ANTI-IGG AND IH-CELL I-II LOT 8003011. IN THE FIRST RUN CELL-I (JKB+) OF IH-CELL I-II YIELDED A QUESTION MARK RESULT AND WAS EDITED TO +/- BY THE USER, CELL-II (JKB-) WAS NEGATIVE. IN THE SECOND RUN BOTH SCREENING CELLS WERE NEGATIVE. THE ANTIBODY WORKSHEET INDICATED THAT THE TEST WAS REPEATED MANUALLY TWICE AND USING IH24 TWICE. PRINT SCREEN FROM IH-COM SHOWED THE WELL IMAGES. THERE APPEARED TO BE AN UNEVEN SURFACE TO THE CELL BUTTON ON CELL-I IN BOTH IMAGES BUT THE SECOND TEST WAS AUTOMATICALLY VERIFIED AS NEGATIVE. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT BECAUSE THE

  Patient problems: Reaction

  MAUDE report 9999902 ↗
• MalfunctionJan 7, 2020Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE IH-1000 GAVE SEVERAL "LIQ (LIQUID) "- ERROR MESSAGES WHEN TESTING SAMPLES IN REVERSE TYPING WITH IH-CELL A1&B AS WELL AS ANTIBODY SCREENING TEST WITH IH-CELL II. THE CORRESPONDING TRACE FILES WERE COLLECTED AND ANALYZED. ACCORDING TO THE TRACE FILE ANALYSIS, THE LIQ INTERPRETATIONS WERE CONFIRMED AND JUSTIFIED. IT WAS NOTICED THAT THE LIQ MESSAGE WAS GIVEN BECAUSE THE CELLS WERE DISPENSED INCORRECTLY (MISSING VOLUME) ON THE BLOOD GROUP TEST AND ANTIBODY SCREENING TEST. FURTHERMORE, THE RESULTS IMAGES CONFIRMED THAT NO CELLS WERE DISTRIBUTED INTO THE WELLS IN CASE OF THE LIQ ERROR. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED, "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULT WAS RELEASED. THE ERROR MESSAGES REQUIRED AN USER INTERACTION SO THAT IT COULD NOT LEAD TO A MISTYPING. BASED ON THE IMAGES OUR TECHNICAL SUPPORT ASSUMED A DIFFERENTIAL PRESSURE INSIDE THE INTERMEDIATE TANK AS A POSSIBLE CAUSE, HENCE IT WAS AN ISSUE REGARDING CUSTOMER SPECIFIC IH-1000 NOT A REAGENT RELATED ISSUE. THIS DIFFERENTIAL PRESSURE MAY AFFECT THE SAMPLING AND THE DISPENSING. THEREFORE, A BIO-RAD TRAINED FIELD SERVICE ENGINEER VISITED THE CUSTO

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

  MAUDE report 9556549 ↗