IH-Cell A1 & B 814010100Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07611969952243), received between Oct 15, 2018 and Mar 31, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (27 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS IN THE B CELL IN REVERSE GROUPING USING IH-CELL A1,B ON TWO DIFFERENT IH-1000 INSTRUMENTS. MANUAL RE-TESTING OF THE SAMPLES YIELDED CORRECT RESULTS, RANGING FROM 3 TO 4+. THE FALSE NEGATIVE REACTION IN THE B CELL WERE RELATED TO ONE 20 YEAR OLD PATIENT WITH LUPUS, ONE 66 YEARS OLD PATIENT WITH MULTIPLE MYELOMA AND ONE 72 YEAR OLD PATIENT WITH SARCOMA. THE CUSTOMER INDICATED THAT THE SAME SITUATION WAS ALSO EXPERIENCED WITH THE PREVIOUS LOST OF IH-CELL A1,B BUT EXAMPLES WERE NOT PROVIDED. THE TRACE FILES OF BOTH AFFECTED INSTRUMENTS WERE REVIEWED. NO LIQ ERROR OCCURRED. VISUALLY THE TOTAL VOLUME IN BOTH WELLS FOR THE REVERSE TEST WERE THE SAME AND AS EXPECTED. THE PELLET SIZE WAS FOUND TO BE NORMAL AND NO INTERPRETATION PROBLEM DUE TO SMALL PELLETS WERE OBSERVED. A DAILY QC HAS BEEN PERFORMED ON THE DATE OF EVENT AND THE EXPECTED RESULTS WERE OBTAINED. BASED ON THIS INFORMATION, REAGENT AND INSTRUMENT ISSUES WERE NOT SUSPECTED. THE INFORMATION WE RECEIVED REGARDING THE PATIENTS INDICATE THAT THE DISCREPANT RESULTS SEEM TO BE RELATED TO THE NATURE OF THE SAMPLES AND THE PATIENTS' UNDERLYING CONDITIONS. CERTAIN DISEASES OR TREATMENTS LIKE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729765 ↗
• MalfunctionSep 11, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE AND WEAK REACTIONS IN REVERSE GROUPING WITH IH-CELL A1,B ON THE IH-1000. MANUAL RE-TESTING OF THE SAMPLES YIELDED CORRECT RESULTS. ACCORDING TO THE CUSTOMER, THIS IS AN ONGOING ISSUE WHICH STARTED AROUND THE END OF (B)(6) AND SHE ESTIMATES THAT IN TOTAL, APPROXIMATELY 20 SUCH FALSE NEGATIVE OR WEAK REACTIONS OCCURRED. SINCE THE CUSTOMER WAS NOT ABLE TO PROVIDE THE DATE OF EVENT(S) FOR RECURRENCE, WE REFRAIN FROM SUBMITTING 20 IDENTICAL REPORTS FOR RANDOMLY CHOOSEN DATES OF EVENT. THE CUSTOMER PROVIDED PLASMA AND CELLS FROM 15 DIFFERENT PATIENTS AND ONE SET OF IH-CELL A1&B FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE AFFECTED LOT AS WELL AS THE PRODUCT SAMPLE PROVIDED BY THE CUSTOMER WITH 21 DIFFERENT DONOR SAMPLES (7X A, 7X B, 7X O, 1X AB BLOOD GROUP) ON THE IH-1000. THE TEST RUN WAS CARRIED OUT USING IH-CARD ABD(DVI-) A1, B LOT 9346030 AND LOT 9374010 WHICH WERE ALSO USED AT THE CUSTOMER'S SITE. ALL SAMPLES REACTED AS EXPECTED, THE REVERSE TYPE MATCHED WITH THE FORWARD TYPE, AND THE REACTION STRENGTHS VARIED FROM 2+ TO 4+. THE PROVIDED PATIENT SAMPLES COULD NOT BE TESTED ON THE IH-1000 DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20188562 ↗
• MalfunctionSep 11, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE AND WEAK REACTIONS IN REVERSE GROUPING WITH IH-CELL A1,B ON THE IH-1000. MANUAL RE-TESTING OF THE SAMPLES YIELDED CORRECT RESULTS. ACCORDING TO THE CUSTOMER, THIS IS AN ONGOING ISSUE WHICH STARTED AROUND THE END OF JULY AND SHE ESTIMATES THAT IN TOTAL, APPROXIMATELY 20 SUCH FALSE NEGATIVE OR WEAK REACTIONS OCCURRED. SINCE THE CUSTOMER WAS NOT ABLE TO PROVIDE THE DATE OF EVENT(S) FOR RECURRENCE, WE REFRAIN FROM SUBMITTING 20 IDENTICAL REPORTS FOR RANDOMLY CHOSEN DATES OF EVENT. THE CUSTOMER PROVIDED PLASMA AND CELLS FROM 15 DIFFERENT PATIENTS AND ONE SET OF IH-CELL A1&B FOR INVESTIGATIONAL TESTING. THE IH-CELLS WERE ALREADY EXPIRED UPON RECEIPT. OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE AFFECTED LOT WITH 21 DIFFERENT DONOR SAMPLES (7X A, 7X B, 7X O, 1X AB BLOOD GROUP) ON THE IH-1000. THE TEST RUN WAS CARRIED OUT USING IH-CARD ABD(DVI-) A1, B LOT 9346030 AND LOT 9374010 WHICH WERE ALSO USED AT THE CUSTOMER'S SITE. ALL SAMPLES REACTED AS EXPECTED, THE REVERSE TYPE MATCHED WITH THE FORWARD TYPE, AND THE REACTION STRENGTHS VARIED FROM 2+ TO 4+. THE PROVIDED PATIENT SAMPLES COULD NOT BE TESTED ON THE IH-1000 DUE TO INSUFFICIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20188459 ↗
• MalfunctionDec 7, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS OF ONE PATIENT SAMPLE. HE EXPERIENCED ISSUES WITH THIS PATIENT SAMPLE IN THE REVERSE TYPING AND THE ANTIBODY SCREENING AND IDENTIFICATION TEST. IN TOTAL TEN DIFFERENT IH PRODUCTS RESPECTIVELY LOTS WERE AFFECTED, THEY ARE LISTED IN SECTION D10. BECAUSE WE CONSIDERED IT VERY UNLIKELY THAT TEN OF OUR PRODUCTS WOULD HAVE FAILED AT THE SAME TIME AND ALL UNEXPECTED RESULTS OCCURRED WITH ONE SPECIFIC PATIENT SAMPLE, WE REFRAIN FROM SUBMITTING TEN REPORTS FOR ALL DIFFERENT PRODUCTS AND LOTS ON THIS SINGLE INCIDENT. THE CUSTOMER DID NOT RETURN PRODUCT SAMPLES FOR INVESTIGATIONAL TESTING BUT THREE SAMPLES OF THE PATIENT IN QUESTION. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE PATIENT SAMPLES TO ARRIVE, THEY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOTS WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. AS SOME OF THE REAGENT RED BLOOD CELLS (RRBCS) HAD ALREADY EXPIRED, THE IH-CARDS USED HERE WERE CHECKED WITH THE CURRENT LOT OF RRBCS (LOT 9338011). THE IH-CARD ABO/D(DVI-)+REV.A1, B LOTS WERE TESTED EACH WITH SIX DIFFERENT DONOR SAMPLES (2 X BLOOD GROUP A, 2 X BLOOD GROUP B, 1 X BLOOD GROUP O AND 1 X BLOOD GROUP AB) A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281822 ↗
• MalfunctionNov 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS OF TWO PATIENT SAMPLES LABELED AS ABV7 AND ABV13 WITH REAGENT RED BLOOD CELL B OF IH-CELL A1&B ON THEIR IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT SAMPLE ABV7 WAS RUN 5 TIMES AND THE IH-CELL B RESULT RANGED FROM NEGATIVE TO 2+. SAMPLE ABV13 WAS RUN 4 TIMES. THE IH-CELL B RESULT RANGED FROM ? TO 2+. THE CUSTOMER DID NEITHER PROVIDE THE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLES THAT HAD CAUSED THE DISCREPANT RESULTS. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE CLAIMED REAGENT RED BLOOD CELL LOT WITH DIFFERENT DONOR SAMPLES (6 X BLOOD GROUP O, 7 X BLOOD GROUP A AND BLOOD GROUP B) AND IH-CARD ABO/D(DVI-)+REV A1, B, THE SAME LOT THE CUSTOMER HAD ALSO USED, ON THE IH-1000. ALL DONOR SAMPLES REACTED SPECIFICALLY. THE B ISOAGGLUTININS WERE DETECTED IN ALL BLOOD GROUP O AND A DONOR SAMPLES AT DIFFERENT REACTION STRENGTHS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THREE DONOR SAMPLES WITH A REACTION STRENGTH OF 1+/2+/2+ WERE USED FOR THE SUBSEQUENT SIMULATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18146168 ↗
• MalfunctionAug 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH IH-CELL A1&B IN THE REVERSE TYPING ON THEIR IH-500 INSTRUMENT. THE CUSTOMER STATED THAT THEY REPEATED ALL SAMPLES IN THE TUBE TEST AND THE REACTIONS WERE CORRECTLY NEGATIVE. THE CUSTOMER DID NOT YET RETURN THE COMPLAINT SAMPLE IH-CELL A1&B FOR INVESTIGATIONAL TESTING BUT ANNOUNCED THE SHIPMENT OF THE COMPLAINT SAMPLE AND PATIENT SAMPLES. IN THE MEANTIME, OUR QUALITY CONTROL TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DONOR SAMPLES ON THE IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION WITH IH-CELL A1&B. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE REQUESTED INSTRUMENT DATA AND IMAGES OF THE AFFECTED IH-500 INSTRUMENT, THE INVESTIGATION IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17601477 ↗
• MalfunctionNov 1, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF TWO PATIENT SAMPLES WITH IH-CELL A1. BOTH PATIENT SAMPLES HAD BLOOD GROUP B. BECAUSE THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION WITHIN ITS SHELF LIFE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. DIFFERENT DONOR SAMPLES WERE MANUALLY TESTED IN PARALLEL WITH A REFERENCE LOT. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY, THE DONORS OF THE SUPPOSEDLY DEFECTIVE LOT WERE TESTED FOR POTENCY IN PARALLEL WITH THE REFERENCE LOT. THE DONOR SAMPLES OF BOTH LOTS SHOWED COMPARABLE RESULTS. WE HAVE NOT OBSERVED ANY WEAKENING OF ANTIGENICITY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT THE CUSTOMER RETURNED THE COMPLAINT SAMPLE IH-CELL A1&B FOR INVESTIGATIONAL TESTING BUT AT THE TIME WE RECEIVED IT, IT WAS ALREADY EXPIRED. ADDITIONALLY, THE CUSTOMER RETURNED FOUR PATIENT SAMPLES LABELED AS #(B)(4) (PLASMA AND RED BLOOD CELLS SEPARATED IN EACH CASE). TESTING OF THE PATIENT SAMPLES IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709685 ↗
• MalfunctionNov 1, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF TWO PATIENT SAMPLES WITH IH-CELL A1. BOTH PATIENT SAMPLES HAD BLOOD GROUP B. BECAUSE THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION WITHIN ITS SHELF LIFE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. DIFFERENT DONOR SAMPLES WERE MANUALLY TESTED IN PARALLEL WITH A REFERENCE LOT. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY, THE DONORS OF THE SUPPOSEDLY DEFECTIVE LOT WERE TESTED FOR POTENCY IN PARALLEL WITH THE REFERENCE LOT. THE DONOR SAMPLES OF BOTH LOTS SHOWED COMPARABLE RESULTS. WE HAVE NOT OBSERVED ANY WEAKENING OF ANTIGENICITY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE IH-CELL A1&B FOR INVESTIGATIONAL TESTING BUT AT THE TIME WE RECEIVED IT, IT WAS ALREADY EXPIRED. ADDITIONALLY, THE CUSTOMER RETURNED FOUR PATIENT SAMPLES LABELED AS #: (B)(6), #: (B)(6), #: (B)(6) AND #: (B)(6) (PLASMA AND RED BLOOD CELLS SEPARATED IN EACH CASE). TESTING OF THE PATIENT SAMPLES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709666 ↗
• MalfunctionOct 11, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS OF TWO PATIENT SAMPLES WITH IH-CELL A1&B ON THE IH-1000 INSTRUMENT. BOTH PATIENT SAMPLES WERE KNOWN TO BE BLOOD GROUP O RHD POSITIVE. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE IH-CELL A1&B FOR INVESTIGATIONAL TESTING NOR THE CUSTOMER SAMPLE THAT HAD CAUSED THE DISCREPANT RESULT.. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY DISCREPANCIES. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. DATA FILES OF THE AFFECTED IH-1000 INSTRUMENT WERE ANALYZED. THE DISTRIBUTION SEQUENCE OF THE REVERSE GROUPING IS CORRECT AND WE DID NOT NOTICE ANY ISSUES. THE VOLUME DISPENSED (CELLS + SERUM) ON THE WELLS A1 AND B WAS CORRECT. THE POSITIVE RESULT WITH IH-CELL A1 AND B WERE AS EXPECTED. BOTH SAMPLES WERE BLOOD GROUP O. ACCORDING TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575952 ↗
• MalfunctionAug 2, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT TWO SAMPLES FROM TWO DIFFERENT PATIENTS WERE NEGATIVE USING IH-CELL A1&B ON IH-1000 BUT STRONG (3-4+) USING MANUAL TUBE METHOD. THE CUSTOMER SPECIFIED THAT THE REACTIONS WITH IH-CELL B OF IH-CELL A1&B WERE FALSE NEGATIVE. THE CUSTOMER STATED THAT REPEAT TESTING USING THE SAME INSTRUMENT AND MANUAL METHODS REPRODUCED THE SAME RESULTS. FURTHERMORE; THE CUSTOMER STATED THAT THE SAMPLES WERE SENT TO ANOTHER LAB IN THE SAME GROUP. THE REVERSE TYPING WAS POSITIVE FOR BOTH SAMPLES ON THE IH-500. THE REACTION STRENGTH WITH IH-CELL B WAS 2+ POSITIVE ON THE IH-500. THE CUSTOMER DID NEITHER RETURN A PRODUCTT SAMPLE FOR INVESTGATIONAL TESTING NOR THE PATIENT SAMPLES THAT CAUSED THE FALSE NEGATIVE TEST RESULTS. THEREFORE; OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE. FIRST, THE QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH SEVERAL DONOR SAMPLES (7X BLOOD GROUP A, 7X BLOOD GROUP O AND 2X BLOOD GROUP B). THE TESTING WAS PERFORMED ON IH-1000, IH-500 AND MANUALLY. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT AND COMPARABLE. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THEN, OUR QUALITY CONTROL LABORATORY TESTED THE DONOR SAMPLES WITH F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143714 ↗
• MalfunctionDec 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT OF A PATIENT WITH THE IH-CELL B OF IH-CELL A1&B ON IH-1000. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES ON IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. THE CUSTOMER PROVIDED THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. THE INVESTIGATION IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. 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

  MAUDE report 12916033 ↗
• MalfunctionNov 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF THREE PATIENT SAMPLES WITH IH-CELL A1 ON THE IH-1000. THE CUSTOMER STATED THAT SHE RAN 3 PATIENTS ON THE IH-1000 THAT WERE GROUP A. ALL THREE PATIENT WERE FORWARD TYPED AND REVERSE TYPED CORRECTLY WITHOUT ANY ISSUES. THESE 3 PATIENTS WERE GIVEN IVIG (INTRAVENOUS IMMUNE GLOBULIN). ALL 3 PATIENTS HAD AN ADDITIONAL DAT TEST ORDERED WHICH WAS POSITIVE. THEY PERFORMED AN ELUATE ON THESE PATIENTS AND THE ELUATE DEMONSTRATED ANTI-A IN THE ELUATE. THIS PROMPTED THE CUSTOMER TO RUN A MANUAL TUBE TEST OF THE FORWARD AND REVERSE TYPING. MANUAL TUBE TESTING ON ALL 3 PATIENTS REVERSE ANTI-A DEMONSTRATED A (3+-4+) POSITIVE REACTION BUT WAS NEGATIVE ON THE IH-1000 AND MANUAL GEL. THE ANTI-A WAS DETERMINED TO LIKELY BE PASSIVE DUE TO RECEIPT OF IVIG. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING BUT SENT THE PATIENT SAMPLES THAT CAUSED THE FALSE NEGATIVE TEST RESULTS. WHILE WE WERE WAITING FOR THE PATIENT SAMPLES, OUR QUALITY CONTROL LABORATORY TEAM TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON THE IH-1000. THE TESTING WAS DONE ON THE RETENTION SAMPLES OF THE IH-CARD LOTS THAT THE CUSTOMER HAD USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12735219 ↗
• MalfunctionNov 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF THREE PATIENT SAMPLES WITH IH-CELL A1 ON THE IH-1000. THE CUSTOMER STATED THAT SHE RAN 3 PATIENTS ON THE IH-1000 THAT WERE GROUP A. ALL THREE PATIENT WERE FORWARD TYPED AND REVERSE TYPED CORRECTLY WITHOUT ANY ISSUES. THESE 3 PATIENTS WERE GIVEN IVIG (INTRAVENOUS IMMUNE GLOBULIN). ALL 3 PATIENTS HAD AN ADDITIONAL DAT TEST ORDERED WHICH WAS POSITIVE. THEY PERFORMED AN ELUATE ON THESE PATIENTS AND THE ELUATE DEMONSTRATED ANTI-A IN THE ELUATE. THIS PROMPTED THE CUSTOMER TO RUN A MANUAL TUBE TEST OF THE FORWARD AND REVERSE TYPING. MANUAL TUBE TESTING ON ALL 3 PATIENTS REVERSE ANTI-A DEMONSTRATED A (3+-4+) POSITIVE REACTION BUT WAS NEGATIVE ON THE IH-1000 AND MANUAL GEL. THE ANTI-A WAS DETERMINED TO LIKELY BE PASSIVE DUE TO RECEIPT OF IVIG. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING BUT SENT THE PATIENT SAMPLES THAT CAUSED THE FALSE NEGATIVE TEST RESULTS. WHILE WE WERE WAITING FOR THE PATIENT SAMPLES, OUR QUALITY CONTROL LABORATORY TEAM TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON THE IH-1000. THE TESTING WAS DONE ON THE RETENTION SAMPLES OF THE IH-CARD LOTS THAT THE CUSTOMER HAD USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12735217 ↗
• MalfunctionAug 26, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO SAMPLES WITH IH-CELL A1 ON IH-1000. BOTH SAMPLES HAD BLOOD GROUP O. THE CUSTOMER PROVIDED IMAGES OF THE DAILY JOURNAL WHICH SHOWED THE FALSE NEGATIVE REACTIONS OF TWO SAMPLES OF BLOOD GROUP A WITH IH-CELL B ON THE IH-1000. DUE TO THE DISCREPANT RESULTS NO WRONG BLOOD GROUP RESULT WAS OUTPUT BUT THE REMARK "ABO DISCREPANCY WORKUP NEEDED". THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE IH-CELL A1, B FOR INVESTIGATIONAL TESTING, BUT ONE PATIENT SAMPLE: #(B)(6). OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT OF IH-CELL A1,B ON THE IH-1000. DIFFERENT DONOR SAMPLES OF BLOOD GROUP A, O, B AND AB WERE USED FOR TESTING. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE RED BLOOD CELLS OF THE PATIENT SAMPLE PROVIDED BY THE CUSTOMER WAS STUCK TO THE INNER SURFACE OF THE TUBE. THEREFORE, THE RED BLOOD CELLS HAD TO BE REMOVED FROM THE SURFACE WITH ISOTONIC SALINE. THE RED BLOOD CELLS AND THE PLASMA WERE TRANSFERRED TO A BABY TUBE. BUT DUE TO THE SMALL AMOUNT OF RED BLOOD CELLS THE IH-1000 DID NOT PROCESS THIS SAMPLE. THEREFORE, OUR QUALITY CONTR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369697 ↗
• MalfunctionAug 26, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO SAMPLES WITH IH-CELL A1 ON IH-1000. BOTH SAMPLES HAD BLOOD GROUP O. THE CUSTOMER PROVIDED IMAGES OF THE DAILY JOURNAL WHICH SHOWED THE FALSE NEGATIVE REACTIONS OF TWO SAMPLES OF BLOOD GROUP A WITH IH-CELL B ON THE IH-1000. DUE TO THE DISCREPANT RESULTS NO WRONG BLOOD GROUP RESULT WAS OUTPUT BUT THE REMARK "ABO DISCREPANCY WORKUP NEEDED". THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE (B)(4) , B FOR INVESTIGATIONAL TESTING, BUT ONE PATIENT SAMPLE: (B)(6). OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT OF IH-CELL A1,B ON THE IH-1000. DIFFERENT DONOR SAMPLES OF BLOOD GROUP A, O, B AND AB WERE USED FOR TESTING. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE RED BLOOD CELLS OF THE PATIENT SAMPLE PROVIDED BY THE CUSTOMER WAS STUCK TO THE INNER SURFACE OF THE TUBE. THEREFORE, THE RED BLOOD CELLS HAD TO BE REMOVED FROM THE SURFACE WITH ISOTONIC SALINE. THE RED BLOOD CELLS AND THE PLASMA WERE TRANSFERRED TO A BABY TUBE. BUT DUE TO THE SMALL AMOUNT OF RED BLOOD CELLS THE IH-1000 DID NOT PROCESS THIS SAMPLE. THEREFORE, OUR QUALITY CONTROL L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369696 ↗
• MalfunctionAug 26, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS OF TWO SAMPLES WITH IH-CELL A1 ON IH-1000. BOTH SAMPLES HAD BLOOD GROUP O. THE CUSTOMER PROVIDED IMAGES OF THE DAILY JOURNAL WHICH SHOWED THE FALSE NEGATIVE REACTIONS OF TWO SAMPLES OF BLOOD GROUP A WITH IH-CELL B ON THE IH-1000. DUE TO THE DISCREPANT RESULTS NO WRONG BLOOD GROUP RESULT WAS OUTPUT BUT THE REMARK "ABO DISCREPANCY WORKUP NEEDED". THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE IH-CELL A1, B FOR INVESTIGATIONAL TESTING, BUT ONE PATIENT SAMPLE: (B)(6). OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT OF IH-CELL A1,B ON THE IH-1000. DIFFERENT DONOR SAMPLES OF BLOOD GROUP A, O, B AND AB WERE USED FOR TESTING. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. THE RED BLOOD CELLS OF THE PATIENT SAMPLE PROVIDED BY THE CUSTOMER WAS STUCK TO THE INNER SURFACE OF THE TUBE. THEREFORE, THE RED BLOOD CELLS HAD TO BE REMOVED FROM THE SURFACE WITH ISOTONIC SALINE. THE RED BLOOD CELLS AND THE PLASMA WERE TRANSFERRED TO A BABY TUBE. BUT DUE TO THE SMALL AMOUNT OF RED BLOOD CELLS THE IH-1000 DID NOT PROCESS THIS SAMPLE. THEREFORE, OUR QUALITY CONTRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369693 ↗
• MalfunctionAug 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A NEGATIVE REVERSE TYPING FROM A TRANSPLANTED PATIENT WITH IH-CELL A1&B ON HIS IH-1000. THE ORIGINAL BLOOD GROUP WAS B RH(D) POSITIVE, THE TRANSPLANTED BONE MARROW HAD BLOOD GROUP A RH(D) POSITIVE. ALSO, IN THE REPEAT TEST ON ANOTHER IH-1000, THE SAMPLE SHOWED NO REACTION IN THE REVERSE TYPING. THE IMMEDIATE SPIN TEST, ON THE OTHER HAND, SHOWED A 2+ POSITIVE REACTION WITH A1 REAGENT RED BLOOD CELLS. THE CROSSMATCH WITH AN A RH(D) DONOR EVEN SHOWED A 4+ POSITIVE REACTION. SINCE NEITHER THE COMPLAINT SAMPLE NOR THE AFFECTED PATIENT SAMPLE WERE SO FAR AVAILABLE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE ON THE IH-1000. DIFFERENT DONOR SAMPLES WERE USED FOR TESTING. THE FOCUS WAS ON BLOOD GROUP B SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY, THE RETENTION SAMPLES OF THE IH-CARD LOTS THE CUSTOMER HAD USED WERE VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE PRESENCE OF A SUPERNATANT. ALL ACCEPTANCE CRITERIA WERE MET. AT THE TIME WE RECEIVED THE MATERIAL THE CUSTOMER HAD SENT IN FOR INVESTIGATIONAL TESTING ALL AFFECTED REAGENT RED BLOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258234 ↗
• MalfunctionAug 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A NEGATIVE REVERSE TYPING FROM A TRANSPLANTED PATIENT WITH IH-CELL A1&B ON HIS IH-1000. THE ORIGINAL BLOOD GROUP WAS B RH(D) POSITIVE, THE TRANSPLANTED BONE MARROW HAD BLOOD GROUP A RH(D) POSITIVE. ALSO, IN THE REPEAT TEST ON ANOTHER IH-1000, THE SAMPLE SHOWED NO REACTION IN THE REVERSE TYPING. THE IMMEDIATE SPIN TEST, ON THE OTHER HAND, SHOWED A 2+ POSITIVE REACTION WITH A1 REAGENT RED BLOOD CELLS. THE CROSSMATCH WITH AN A RH(D) DONOR EVEN SHOWED A 4+ POSITIVE REACTION. SINCE NEITHER THE COMPLAINT SAMPLE NOR THE AFFECTED PATIENT SAMPLE WERE SO FAR AVAILABLE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE ON THE IH-1000. DIFFERENT DONOR SAMPLES WERE USED FOR TESTING. THE FOCUS WAS ON BLOOD GROUP B SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY, THE RETENTION SAMPLES OF THE IH-CARD LOTS THE CUSTOMER HAD USED WERE VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE PRESENCE OF A SUPERNATANT. ALL ACCEPTANCE CRITERIA WERE MET. AT THE TIME WE RECEIVED THE MATERIAL THE CUSTOMER HAD SENT IN FOR INVESTIGATIONAL TESTING ALL AFFECTED REAGENT RED BLOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258223 ↗
• MalfunctionAug 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A NEGATIVE REVERSE TYPING FROM A TRANSPLANTED PATIENT WITH IH-CELL A1&B ON HIS IH-1000. THE ORIGINAL BLOOD GROUP WAS B RH(D) POSITIVE, THE TRANSPLANTED BONE MARROW HAD BLOOD GROUP A RH(D) POSITIVE. ALSO, IN THE REPEAT TEST ON ANOTHER IH-1000, THE SAMPLE SHOWED NO REACTION IN THE REVERSE TYPING. THE IMMEDIATE SPIN TEST, ON THE OTHER HAND, SHOWED A 2+ POSITIVE REACTION WITH A1 REAGENT RED BLOOD CELLS. THE CROSSMATCH WITH AN A RH(D) DONOR EVEN SHOWED A 4+ POSITIVE REACTION. SINCE NEITHER THE COMPLAINT SAMPLE NOR THE AFFECTED PATIENT SAMPLE WERE SO FAR AVAILABLE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE ON THE IH-1000. DIFFERENT DONOR SAMPLES WERE USED FOR TESTING. THE FOCUS WAS ON BLOOD GROUP B SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY, THE RETENTION SAMPLES OF THE IH-CARD LOTS THE CUSTOMER HAD USED WERE VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE PRESENCE OF A SUPERNATANT. ALL ACCEPTANCE CRITERIA WERE MET. AT THE TIME WE RECEIVED THE MATERIAL THE CUSTOMER HAD SENT IN FOR INVESTIGATIONAL TESTING ALL AFFECTED REAGENT RED BLOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258212 ↗
• MalfunctionAug 2, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A NEGATIVE REVERSE TYPING FROM A TRANSPLANTED PATIENT WITH IH-CELL A1&B ON HIS IH-1000. THE ORIGINAL BLOOD GROUP WAS B RH(D) POSITIVE, THE TRANSPLANTED BONE MARROW HAD BLOOD GROUP A RH(D) POSITIVE. ALSO, IN THE REPEAT TEST ON ANOTHER IH-1000, THE SAMPLE SHOWED NO REACTION IN THE REVERSE TYPING. THE IMMEDIATE SPIN TEST, ON THE OTHER HAND, SHOWED A 2+ POSITIVE REACTION WITH A1 REAGENT RED BLOOD CELLS. THE CROSSMATCH WITH AN A RH(D) DONOR EVEN SHOWED A 4+ POSITIVE REACTION. SINCE NEITHER THE COMPLAINT SAMPLE NOR THE AFFECTED PATIENT SAMPLE WERE SO FAR AVAILABLE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE ON THE IH-1000. DIFFERENT DONOR SAMPLES WERE USED FOR TESTING. THE FOCUS WAS ON BLOOD GROUP B SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. ADDITIONALLY, THE RETENTION SAMPLES OF THE IH-CARD LOTS THE CUSTOMER HAD USED WERE VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE PRESENCE OF A SUPERNATANT. ALL ACCEPTANCE CRITERIA WERE MET. AT THE TIME WE RECEIVED THE MATERIAL THE CUSTOMER HAD SENT IN FOR INVESTIGATIONAL TESTING ALL AFFECTED REAGENT RED BLOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258206 ↗
• MalfunctionMay 12, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A CAP SURVEY SAMPLE WITH IH-CELL A1&B. THE CAP SURVEY SAMPLE HAD BLOOD GROUP AB AND WOULD THEREFORE BE EXPECTED TO REACT NEGATIVELY WITH IH-CELL A1&B. THE CUSTOMER INFORMED US THAT THE CAP SURVEY SAMPLE ADDITIONALLY CONTAINED AN ANTI-S. THE CUSTOMER RETURNED THE COMPLAINT SAMPLE OF IH-CELL A1&B FOR INVESTIGATIONAL TESTING AND A SMALL AMOUNT OF THE CAP SURVEY SAMPLE. OUR QUALITY CONTROL LABORATORY TESTED MANUALLY THE COMPLAINT SAMPLE WITH THE CAP SURVEY SAMPLE. THE REACTIONS WITH IH-CELL A1&B WERE NEGATIVE. ADDITIONALLY, THE CAP SURVEY SAMPLE WAS MANUALLY TESTED WITH OUR QC LAB'S RETENTION SAMPLE. IH-CELL B SHOWED A WEAK POSITIVE REACTION, WHILE THE REACTION WITH IH-CELL A1 WAS NEGATIVE. FURTHERMORE, A KNOWN ANTI-S (MONOCLONAL, IGM) WAS TESTED WITH BOTH IH-CELL A1&B, THE COMPLAINT SAMPLE RETURNED BY THE CUSTOMER AND OUR QC LAB'S RETENTION SAMPLE. IN BOTH CASES IH-CELL A1&B SHOWED CLEARLY POSITIVE RESULTS. IH-CELL A1&B CONSISTS OF A POOL OF TWO DONORS EACH. INDIVIDUAL DONORS ARE TESTED FOR THE PRESENCE OF S ANTIGEN. THREE OF THE FOUR DONORS WERE S POSITIVE. THE CAP SURVEY SAMPLE WAS ALSO TESTED IN THE ANTIBODY SCREENING TEST IN THE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812537 ↗
• MalfunctionNov 20, 2019False Negative Result

  THE CUSTOMER REPORTED DISCREPANT RESULTS IN REVERSE TYPING ON IH-1000. THE CUSTOMER USED IH-CELL A1&B AND IH-CARD ABO/D(DVI+)+REV A1,B (LOT NO. 8912020) AND IH-CARD ABO/D(DVI-)+REV A1, B (LOT NO. 8920030). THE CUSTOMER STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE, THE CUSTOMER STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER PROVIDED SCREEN PRINTS OF SIX (6) SAMPLES THAT CONFIRMED THE FALSE NEGATIVE REACTIONS IN REVERSE TYPING ON IH-1000 BUT NO FURTHER INFORMATION ABOUT THE PATIENT CLINICAL DETAILS. HOWEVER, THE CUSTOMER PROVIDED THESE 6 SAMPLES TESTED BETWEEN (B)(6 2019 AND (B)(6) 2019 USING THE PREVIOUSLY MENTIONED PRODUCTS. REVIEW OF THE FILES FOR 1 OF THE SAMPLES INDICATED THERE WERE NO INSTRUMENT ERRORS NOTED DURING THE TESTING. CORRECT VOLUMES OF SAMPLE AND IH-CELL A1&B WERE DISPENSED INTO THE WELLS. HOWEVER, FILES WERE NOT AVAILABLE FOR THE REMAINING 5 SAMPLES. THE 6 SAMPLES WERE TESTED WITH IH-CELL A1&B, LOT 8939011, 8943011 AND REVERSE

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

  MAUDE report 9346571 ↗
• MalfunctionNov 20, 2019False Negative Result

  THE CUSTOMER REPORTED DISCREPANT RESULTS IN REVERSE TYPING ON IH-1000. THE CUSTOMER USED IH-CELL A1&B AND IH-CARD ABO/D(DVI+)+REV A1,B (LOT NO. 8912020) AND IH-CARD ABO/D(DVI-)+REV A1, B (LOT NO. 8920030). THE CUSTOMER STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE, THE CUSTOMER STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER PROVIDED SCREEN PRINTS OF SIX (6) SAMPLES THAT CONFIRMED THE FALSE NEGATIVE REACTIONS IN REVERSE TYPING ON IH-1000 BUT NO FURTHER INFORMATION ABOUT THE PATIENT CLINICAL DETAILS. HOWEVER, THE CUSTOMER PROVIDED THESE 6 SAMPLES TESTED BETWEEN (B)(6) 2019 USING THE PREVIOUSLY MENTIONED PRODUCTS. REVIEW OF THE FILES FOR 1 OF THE SAMPLES INDICATED THERE WERE NO INSTRUMENT ERRORS NOTED DURING THE TESTING. CORRECT VOLUMES OF SAMPLE AND IH-CELL A1&B WERE DISPENSED INTO THE WELLS. HOWEVER, FILES WERE NOT AVAILABLE FOR THE REMAINING 5 SAMPLES. THE 6 SAMPLES WERE TESTED WITH IH-CELL A1&B, LOT 8939011, 8943011 AND REVERSE GROUP CELLS FRO

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

  MAUDE report 9346548 ↗
• MalfunctionNov 20, 2019False Negative Result

  THE CUSTOMER REPORTED DISCREPANT RESULTS IN REVERSE TYPING ON IH-1000. THE CUSTOMER USED IH-CELL A1&B AND IH-CARD ABO/D(DVI+)+REV A1,B (LOT NO. 8912020) AND IH-CARD ABO/D(DVI-)+REV A1, B (LOT NO. 8920030). THE CUSTOMER STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE, THE CUSTOMER STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER PROVIDED SCREEN PRINTS OF SIX (6) SAMPLES THAT CONFIRMED THE FALSE NEGATIVE REACTIONS IN REVERSE TYPING ON IH-1000 BUT NO FURTHER INFORMATION ABOUT THE PATIENT CLINICAL DETAILS. HOWEVER, THE CUSTOMER PROVIDED THESE 6 SAMPLES TESTED BETWEEN (B)(6) 2019 USING THE PREVIOUSLY MENTIONED PRODUCTS. REVIEW OF THE FILES FOR 1 OF THE SAMPLES INDICATED THERE WERE NO INSTRUMENT ERRORS NOTED DURING THE TESTING. CORRECT VOLUMES OF SAMPLE AND IH-CELL A1&B WERE DISPENSED INTO THE WELLS. HOWEVER, FILES WERE NOT AVAILABLE FOR THE REMAINING 5 SAMPLES. THE 6 SAMPLES WERE TESTED WITH IH-CELL A1&B, LOT 8939011, 8943011 AND REVERSE GROUP CELLS FRO

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

  MAUDE report 9346547 ↗
• MalfunctionOct 23, 2019False Negative Result

  THE CUSTOMER REPORTED THAT THE SAMPLE OF A PREGNANT 35 YEAR OLD FEMALE ADMITTED FOR PREECLAMPSIA SHOWED A FALSE NEGATIVE REACTION WITH CELL B OF IH-CELL A1&B ON IH-1000. THE CUSTOMER STATED THAT THE FEMALE HAD THE KNOWN BLOOD GROUP A RH(D) POSITIVE. THE SAMPLE OF THE PREGNANT FEMALE SHOWED A POSITIVE RESULT IN THE TUBE TEST WITH CELL B. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, BUT THREE SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. BECAUSE THE PATIENT SAMPLES WERE NOT SUITABLE FOR TESTING ON IH-1000 OUR PRODUCT SUPPORT LABORATORY TESTED THE SAMPLES MANUALLY WITH THEIR RETENTION SAMPLE OF IH-CELL A1&B. PATIENT SAMPLE #1 AND #2 GAVE A POSITIVE RESULT, WHILE PATIENT SAMPLE #3 GAVE A NEGATIVE RESULT. FURTHERMORE PATIENT SAMPLE #3 WAS TESTED IN THE TUBE TECHNIQUE AND GAVE A CLEARLY POSITIVE RESULT. PATIENT SAMPLE 3 WAS ADDITIONALLY TESTED IN AN ALTERNATIVE GEL METHOD AND ALSO GAVE A NEGATIVE RESULT. IT CAN OCCUR THAT PATIENT SAMPLES WITH LOW TITRE ISOAGGLUTININS MAY LEAD TO WEAK AND SOMETIMES

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

  MAUDE report 9223910 ↗