IH-Cell I-II-III 814030100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611969952267), received between Aug 7, 2017 and Aug 28, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED DISCREPANCIES IN THE ANTIBODY SCREENING/IDENTIFICATION TEST. ONE PATIENT PREVIOUSLY FOUND TO BE ANTIBODY-NEGATIVE REACTED POSITIVE FOR ANTIBODIES BUT ONLY WITH ONE SPECIFIC BLOOD SAMPLE TUBE. SAMPLE NO. (B)(4) WAS DRAWN POST-TRANSFUSION ON JULY 28TH. IT REACTED POSITIVE IN ALL TESTS RUN - ANTIBODY SCREEN, ANTIBODY IDENTIFICATION, AUTOCONTROL AND CROSSMATCHES. NO DISCERNABLE ANTIBODY SPECIFICITY COULD BE DETECTED. DUE TO THE WORK-UP THIS SAMPLE WAS USED UP. A SECOND SAMPLE FROM THE SAME DAY WAS TESTED AND SHOWED NO REACTIONS AT ALL. THIS SAMPLE (CBC- COMPLETE BLOOD COUNT USED IN HEMATOLOGY) WAS NOT DRAWN AT THE SAME TIME AS SAMPLE NO. (B)(4) BUT THERE WAS A GAP IN BETWEEN. ALL TESTS PERFORMED AFTER THE POST-TRANSFUSION SAMPLE WERE ANTIBODY SCREEN NEGATIVE. THE SAME LOT IF IH-CELL I-II-III WAS USED BEFORE AND AFTER THE POSITIVE REACTIONS. THE CUSTOMER PROVIDED CELLS AND PLASMA FROM TWO SAMPLES DRAWN PRIOR TO THE POSITIVE ANTIBODY SCREEN, AND FROM THREE SAMPLES DRAWN AFTER TO THE POSITIVE ANTIBODY SCREEN. FROM THE AFFECTED BLOOD SAMPLE TUBE ONLY RED CELLS COULD BE PROVIDED. FURTHERMORE, VIALS FROM THE COMPLAINED LOT OF IH-CELL I-II-III WERE RETURNED FOR INVESTIGA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083908 ↗
• MalfunctionJul 31, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED ON-GOING INCONSISTENT RESULTS WITH THE SCREENING REAGENT RED BLOOD CELLS ON THEIR IH-1000 INSTRUMENT. AN ANTI-K WAS TESTED ON THE IH-1000 WITH IH-CELL I-II-III LOT 9422011 AND ON IH-CARD AHG ANTI-IGG 9342010. A NEGATIVE REACTION WAS OBTAINED WITH CELL NO.3 OF IH-CELL I-II-III WHICH IS K+K+. THE SAME SAMPLE WAS REPEATED 3 DAYS LATER ON THE SAME IH-1000 INSTRUMENT AND SHOWED A POSITIVE, BUT WEAK REACTION WITH CELL NO. 3. THE CUSTOMER ANNOUNCED NOT TO RETURN PRODUCT SAMPLES OF THE ALLEGEDLY DEFECTIVE PRODUCTS FOR INVESTIGATIONAL TESTING AND ALSO NO PATIENT MATERIAL. THEREFORE, OUR QUALITY CONTROL TESTED 6 KNOWN ANTI-K IN TRIPLICATE WITH THEIR RETENTION SAMPLES OF IH-CELL I-II-III LOT 9422011 AND IH-CARD AHG ANTI-IGG 9342010 ON TWO DIFFERENT IH-1000 INSTRUMENTS. WE DID NOT OBTAIN ANY FALSE NEGATIVE REACTIONS OR INCONSISTENCY, IN EACH TEST RUN CELL NO. 3 SHOWED A CLEAR POSITIVE REACTION. THE ANTI-K ANTIBODIES WERE ALSO TESTED IN THE MANUAL GEL TEST METHOD AND A "WAITING-TIME" OF 10 MINUTES WAS SIMULATED BEFORE CENTRIFUGATION. LASTLY, THE MANUAL PIPETTING WAS PERFORMED WITH A SIMULATED BROKEN AIR GAP BETWEEN TEST MATERIAL AND THE AHG. AGAIN, IN BOTH SCENARIOS NO FAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19869662 ↗
• MalfunctionMay 9, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF TWO PATIENT SAMPLES WITH IH-CELL I-II-III ON THE IH-500 INSTRUMENT. THE CUSTOMER STATED THAT SAMPLE #(B)(6) (BLOOD GROUP O) CONTAINED THE ANTIBODIES ANTI-C AND ANTI-E AND SAMPLE #(B)(6) (BLOOD GROUP A) ANTI-C AND ANTI-JKB. THE CUSTOMER WAS CONCERNED THAT NOT ALL LITTLE C REACTIVE CELLS ON THE BIO-RAD ANTIBODY DETECTION AND IDENTIFICATION PANELS REACTED WITH SAMPLE (B)(6). THEY ARE ALSO CONCERNED THAT NOT ALL JKB REACTIVE CELLS ON THE BIO-RAD ANTIBODY DETECTION AND IDENTIFICATION PANELS REACTED WITH SAMPLE (B)(6).THE MISSED ANTIBODIES WERE IDENTIFIED BY THE AMERICAN RED CROSS USING THE TUBE METHOD WITH THE ENHANCEMENT MEDIUM PEG (POLYETHYLENE GLYCOL). THE CUSTOMER DID NEITHER PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-CELL I-II-III FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON THE IH-500. OUR QUALITY CONTROL LABORATORY USED THREE KNOWN ANTIBODIES (ANTI-C, ANTI-E AND ANTI-JKB ) AND DONOR SAMPLES FOR TESTING. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16893599 ↗
• MalfunctionFeb 14, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE ANTIBODY SCREENING RESULT OF A PATIENT SAMPLE WITH IH-CELL I-II-III ON THE IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE PATIENT IN QUESTION WAS TESTED TWICE ON THE IH-1000. IN THE FIST TESTING THE PATIENT SAMPLE YIELDED A POSITIVE RESULT WITH CELL #2 OF IH-CELL I-II-III, BUT IN THE SECOND TEST THE ANTIBODY SCREENING TEST WAS NEGATIVE ON THE IH-1000. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE IH-CELL I-II-III FOR INVESTIGATIONAL TESTING AND ALSO THE PATIENT SAMPLE LABELED AS #(B)(6) (PLASMA AND RED BLOOD CELLS SEPARATED) THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. AT THE TIME THE MATERIAL FROM THE CUSTOMER ON OUR PROMISES, THE SUPPOSEDLY DEFECTIVE LOT WAS ALREADY EXPIRED. WHILE OUR QUALITY CONTROL LABORATORY WAITED FOR THE MATERIAL ANNOUNCED BY THE CUSTOMER, THEY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH KNOWN ANTIBODIES (ANTI-D AND ANTI-E) AND DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16370186 ↗
• MalfunctionApr 23, 2020False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF ONE PATIENT SAMPLE WHEN TESTED WITH IH-CELL I-II-III ON IH-1000. THE CUSTOMER STATED THAT THE CUSTOMER HAD A KNOWN ANTI-E AND ANTI-LU(A). THE CUSTOMER RETURNED NEITHER THE COMPLAINT SAMPLE IH-CELL I-II-III FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVES, BUT AGREED TO FORWARD THE TRACE FILES OF THE IH-1000. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IH-CELL I-II-III WITH DIFFERENT CONTROLS AND SAMPLES ON IH-1000, E.G. ANTI-E AND ANTI-LU(A) . ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. WE ARE STILL WAITING FOR THE TRACE FILES OF THE IH-1000 FOR INVESTIGATION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF IH-CELL I-II-III FUNCTIONS 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 Known Impact Or Consequence To Patient

  MAUDE report 9990089 ↗
• MalfunctionApr 23, 2020False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF ONE PATIENT SAMPLE WHEN TESTED WITH IH-CELL I-II-III ON IH-1000. THE CUSTOMER STATED THAT THE CUSTOMER HAD A KNOWN ANTI-E AND ANTI-LU(A). THE CUSTOMER RETURNED NEITHER THE COMPLAINT SAMPLE IH-CELL I-II-III FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED FALSE NEGATIVES, BUT FORWARDED THE TRACE FILES OF THE IH-1000. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT OF IH-CELL I-II-III WITH DIFFERENT CONTROLS AND SAMPLES ON IH-1000, E.G. ANTI-E AND ANTI-LU(A) . ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE TRACE FILES WERE REVIEWED. THE OUTCOME OF THE INVESTIGATION WAS A CONFIRMATION THAT THE ANTIBODY SCREENING TEST RESULTS WERE CLEARLY NEGATIVE ON THE BOTH DATES. BUT BASED ON THE PANEL RESULTS, THE REACTION WAS NOT COMPATIBLE WITH ANTI-E AND ANTI-LU(A), HOWEVER IT WAS FOR ANTI-C. BECAUSE THE AFFECTED SAMPLE WAS NO MORE AVAILABLE FOR FURTHER INVESTIGATION AND TESTING, THIS DISCREPANCY COULD NOT BE SOLVED. BUT WE COULD NOT IDENTIFY ANY INSTRUMENT MALFUNCTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE

  Patient problems: Reaction

  MAUDE report 9990088 ↗
• MalfunctionAug 7, 2017False Negative Result; Incorrect Or Inadequate Test Results

  A CUSTOMER REPORTED DISCREPANT TEST RESULTS WITH IH-CELL I-II-III BETWEEN ECHO (DEVICE MANUFACTURED BY A COMPETITOR) AND IH-1000 WHEN PERFORMING VALIDATION. THE ECHO GAVE A 3+ POSITIVE RESULT AND TWO IH-1000 ANALYZERS GAVE NEGATIVE RESULTS DURING PROCESSING AN ANTIBODY SCREENING. ADDITIONALLY PERFORMED TUBE LISS AND TUBE PEG TESTING BOTH GAVE NEGATIVE RESULTS. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. WE ARE STILL WAITING FOR THE PATIENT SAMPLE. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. 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 Known Impact Or Consequence To Patient

  MAUDE report 6770091 ↗