IH-Panel 11 814070100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07611969952298), received between Sep 11, 2018 and Feb 11, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026False Negative Result

  A PATIENT HAD A CONFIRMED ANTI-C, WHICH WE LATER LEARNED HAD ALSO BEEN IDENTIFIED AT (B)(6). THE ANTIBODY WAS IDENTIFIED WITHOUT ISSUE, AND THERE WAS NO INITIAL REASON TO SUSPECT ADDITIONAL ANTIBODIES. GIVEN THAT WE ARE ACTIVELY INVESTIGATING SEVERAL ISSUES WITH TECHNICAL SUPPORT, WE ELECTED TO RUN A PAPAIN PANEL. THIS REVEALED AN ANTI-E. UPON QUESTIONING, THE PATIENT'S HUSBAND (A RETIRED PATHOLOGIST WITH EXCELLENT RECALL) STATED THAT SHE WAS KNOWN TO HAVE ANTI-E DATING BACK TO THE 1970S AT (B)(6) HOSPITAL IN (B)(6). THE PATIENT REPORTS NO TRANSFUSION HISTORY BUT HAS HAD THREE PREGNANCIES AND WAS PREVIOUSLY APPROACHED BY ORTHO FOR PLASMA DONATION DUE TO A "RARE ANTIBODY." WE RECOGNIZE THAT PAPAIN ENHANCES RH ANTIBODIES; HOWEVER, UNDER ROUTINE CIRCUMSTANCES, WE WOULD NOT HAVE RUN PAPAIN WITHOUT THIS ADDITIONAL HISTORICAL INFORMATION WHICH IS TYPICALLY UNAVAILABLE AT THE TIME OF TESTING. IN THIS CASE, TRANSFUSING E-POSITIVE RED CELLS COULD HAVE RESULTED IN A DELAYED HEMOLYTIC TRANSFUSION REACTION. INVESTIGATION: ACCORDING TO THE DATA PROVIDED, THE IH-CELL III IN ANTIBODY SCREENING TEST AND IH-CELL 4, 6, 7, 8, 9, 10 AND 11 IN THE ANTIBODY IDENTIFICATION TEST ARE NOT REACTING WITH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313203 ↗
• MalfunctionFeb 11, 2026False Negative Result

  A PATIENT WAS IDENTIFIED AS CARRYING AN ALLOANTIBODY, ANTI[-K, USING THE GEL METHOD. TO FURTHER INVESTIGATE, THE LABORATORY PERFORMED AN ADDITIONAL ANTIBODY IDENTIFICATION USING TUBE TESTING WITH PAPAIN, WHICH REVEALED A SECOND ALLOANTIBODY, ANTI-E. THIS ANTI-E WAS NOT DETECTABLE USING THE IH-PANEL 11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312973 ↗
• MalfunctionDec 19, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED THAT CELL 6 OF IH-PANEL 11 DID NOT DETECT AN ANTI-E WHEN USED ON THE IH-1000. THE CUSTOMER OBTAINED THE FOLLOWING RESULTS FOR A PATIENT SAMPLE CONTAINING AN ANTI-E ANTIBODY: · ANTIBODY SCREENING TEST WITH IH-CELL I-II-III WITH A WEAK POSITIVE RESULT ON THE IH-CELL II (CORRESPOND TO ANTI-E ANTIBODY). · IDENTIFICATION TEST WITH IH-PANEL 11 WITH NEGATIVE RESULT ON ALL CELLS · IDENTIFICATION TEST WITH IH-PANEL 11 PAPAIN WITH A WEAK POSITIVE RESULT ON THE IH-PANEL 2 (IH-PANEL 6 NEGATIVE, ANTI-E ANTIBODY NOT IDENTIFIABLE). OUR QUALITY CONTROL LABORATORY CHECKED OUR RETENTION SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT. FIRST, THE LOT WAS VISUALLY CHECKED AND NO ABNORMALITIES WERE OBSERVED IN THE CELLS. FURTHERMORE, TWO KNOWN ANTI-E ANTIBODIES AND ONE ANTIBODY FREE DONOR SAMPLE WERE TESTED ON THE IH-1000. ALL REACTIONS WERE SPECIFIC; NOT FALSE NEGATIVE REACTION OCCURRED WITH THE ANTI-E SAMPLE AND THE E ANTIGEN POSITIVE TEST CELLS. TRACE FILES OF THE AFFECTED IH-1000 INSTRUMENT HAVE BEEN ANALYZED, THERE IS NO MISFUNCTION FROM THE INSTRUMENT. ACCORDING TO THE DATA PROVIDED, THE CUSTOMER IS NOT ABLE TO IDENTIFY THE ANTI-E ANTIBODY WITH THE IDENTIFICATION TEST, ALL CELLS ARE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849620 ↗
• MalfunctionOct 22, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANT RESULTS OF THREE (3) PATIENT SAMPLES USING THE IH-PANEL 11 LOT 9430011 ON THEIR IH-1000 INSTRUMENT. THE INITIAL ANTIBODY SCREEN TESTS INDICATED THE PRESENCE OF AN ANTIBODY, HOWEVER THE ANTIBODY IDENTIFICATION TESTS CAME BACK NEGATIVE. ADDITIONAL TESTS USING THE PEG TUBE METHOD IDENTIFIED THE ANTIBODIES. THE CUSTOMER PROVIDED ONE SET OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-PANEL 11 FOR INVESTIGATIONAL TESTING ANS ALSO MATERIAL OF THREE PATIENT SAMPLES: NO. (B)(6). FOR SAMPLE (B)(6) THE PLASMA WAS LEAKED OUT. AT THE TIME THE CUSTOMER FILED HER COMPLAINT, THE AFFECTED PRODUCT IH-PANEL 11 LOT 9430011 HAD ALREADY BEEN EXPIRED. FURTHERMORE, THE PLASMA OF TWO PATIENT SAMPLES WAS LEAKED OUT (B)(6), THEREFORE NO TESTINGS WERE POSSIBLE. FOR SAMPLE (B)(6) (ANTI-C AND NON SPECIFIC ANTIBODY) ONLY A SMALL AMOUNT OF PLASMA WAS AVAILABLE, THEREFORE THE TESTING WAS RESTRICTED TO SELECTED CELLS ONLY. DESPITE OF THE EXCEEDED EXPIRY DATE THE C-ANTIGEN POSITIVE TEST CELLS OF IH-PANEL 11 LOT 9430011 WERE USED FOR COMPLAINT TESTING. FIRST OF ALL, THE ANTIGENICITY OF THE CELLS WAS CONFIRMED BY THE DETERMINATION OF THE TITER USING A POLYCLONAL ANTI-C, IN COMPARISON TO THE C-A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504528 ↗
• MalfunctionOct 22, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANT RESULTS OF THREE (3) PATIENT SAMPLES USING THE IH-PANEL 11 LOT 9430011 ON THEIR IH-1000 INSTRUMENT. THE INITIAL ANTIBODY SCREEN TESTS INDICATED THE PRESENCE OF AN ANTIBODY, HOWEVER THE ANTIBODY IDENTIFICATION TESTS CAME BACK NEGATIVE. ADDITIONAL TESTS USING THE PEG TUBE METHOD IDENTIFIED THE ANTIBODIES. THE CUSTOMER PROVIDED ONE SET OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-PANEL 11 FOR INVESTIGATIONAL TESTING ANS ALSO MATERIAL OF THREE PATIENT SAMPLES: NO. (B)(6). FOR SAMPLE (B)(6) THE PLASMA WAS LEAKED OUT. AT THE TIME THE CUSTOMER FILED HER COMPLAINT, THE AFFECTED PRODUCT IH-PANEL 11 LOT 9430011 HAD ALREADY BEEN EXPIRED. FURTHERMORE, THE PLASMA OF TWO PATIENT SAMPLES WAS LEAKED OUT (B)(6), THEREFORE NO TESTINGS WERE POSSIBLE. FOR SAMPLE (B)(6) (ANTI-C AND NON SPECIFIC ANTIBODY) ONLY A SMALL AMOUNT OF PLASMA WAS AVAILABLE, THEREFORE THE TESTING WAS RESTRICTED TO SELECTED CELLS ONLY. DESPITE OF THE EXCEEDED EXPIRY DATE THE C-ANTIGEN POSITIVE TEST CELLS OF IH-PANEL 11 LOT 9430011 WERE USED FOR COMPLAINT TESTING. FIRST OF ALL, THE ANTIGENICITY OF THE CELLS WAS CONFIRMED BY THE DETERMINATION OF THE TITER USING A POLYCLONAL ANTI-C, IN COMPARISON TO THE C-A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504514 ↗
• MalfunctionOct 22, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANT RESULTS OF THREE (3) PATIENT SAMPLES USING THE IH-PANEL 11 LOT: 9430011 ON THEIR IH-1000 INSTRUMENT. THE INITIAL ANTIBODY SCREEN TESTS INDICATED THE PRESENCE OF AN ANTIBODY; HOWEVER, THE ANTIBODY IDENTIFICATION TESTS CAME BACK NEGATIVE. ADDITIONAL TESTS USING THE PEG TUBE METHOD IDENTIFIED THE ANTIBODIES. THE CUSTOMER PROVIDED ONE SET OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-PANEL 11 FOR INVESTIGATIONAL TESTING AND ALSO MATERIAL OF THREE PATIENT SAMPLES: NO. (B)(6). FOR SAMPLE (B)(6) THE PLASMA WAS LEAKED OUT. AT THE TIME THE CUSTOMER FILED HER COMPLAINT, THE AFFECTED PRODUCT IH-PANEL 11 LOT: 9430011 HAD ALREADY BEEN EXPIRED. FURTHERMORE, THE PLASMA OF TWO PATIENT SAMPLES WAS LEAKED OUT (B)(6), THEREFORE, NO TESTINGS WERE POSSIBLE. FOR SAMPLE (B)(6) (ANTI-C AND NON-SPECIFIC ANTIBODY) ONLY A SMALL AMOUNT OF PLASMA WAS AVAILABLE, THEREFORE THE TESTING WAS RESTRICTED TO SELECTED CELLS ONLY. DESPITE OF THE EXCEEDED EXPIRY DATE THE C-ANTIGEN POSITIVE TEST CELLS OF IH-PANEL 11 LOT: 9430011 WERE USED FOR COMPLAINT TESTING. FIRST OF ALL, THE ANTIGENICITY OF THE CELLS WAS CONFIRMED BY THE DETERMINATION OF THE TITER USING A POLYCLONAL ANTI-C, IN COMPARISON TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504456 ↗
• MalfunctionMar 21, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF CELL NO. 8 (DONOR NO. 103493) OF IH-PANEL 11 WITH ANTI-N. ACCORDING TO THE ANTIGEN TABLE CELL NO. 8 WAS N ANTIGEN NEGATIVE, BUT MMSS. THE CUSTOMER STATED THAT THEY RECEIVED A POSITIVE REACTION WITH CELL NO.8 OF IH-PANEL 11 AND SERACLONE ANTI-N. THE CUSTOMER INTENDS TO RETURN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESING BUT HASN'T DONE SO YET.. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. CELL NO.8 OF IH-PANEL 11 WAS TESTED WITH SERACLONE ANTI-M AND SERACLONE ANTI-N ACCORDING TO THE INSTRUCTION FOR USE (TUBE TEST, INCUBATION FOR 30 MINUTES AT ROOM TEMPERATURE, READING OF THE RESULTS; NO CENTRIFUGATION). CELL NO.8 OF IH-PANEL 11 SHOWED A CORRECTLY NEGATIVE RESULT WITH SERACLONE ANTI-N, WHILE THE REACTION WITH SERACLONE ANTI-M WAS CORRECTLY POSITIVE. THE POSITIVE AND NEGATIVE CONTROLS ALSO SHOWED A CORRECT RESULT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. BASED ON THE CURRENT TESTS OF OUR QUALITY CONTROL LABORATORY, A MISTYPING OF CELL NO. 8 OF IH-PANELL 11 (DONOR NO. 103493) CAN BE EXCLUDED. THE DONOR 103493 HAS ALREADY BEEN IN USE FOR THE PANED REAGENT RED BLOOD CELLS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948863 ↗
• MalfunctionOct 10, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION WITH IH-PANEL 11 ON THE IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-E. ACCORDING TO THE ANTIGEN TABLE THE REAGENT RED BLOOD CELLS #2 AND #6 WERE E ANTIGEN POSITIVE AND THEREFORE SUPPOSED TO REACT POSITIVELY. THE CUSTOMER STATED THAT THE PATIENT SAMPLE SHOWED WEAK POSITIVE REACTIONS WITH IH-PANEL PLUS 6. THEREFORE, THE CUSTOMER COMPLAINED ONLY ABOUT THE IH-PANEL 11. THE EXACT DATE OF EVENT IS NOT KNOWN, SO WE ASSUMED THE DATE OF AWARENESS ALSO TO BE THE DATE OF EVENT. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE OF THE ALLEGEDLY DEFECTIVE LOT 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 LOT ON THE IH-1000. THE TESTING WAS PERFORMED WITH KNOWN ANTIBODIES (ANTI-E, ANTI-D AND ANTI-FY(A)) AND DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. THE ANTI-E COULD BE IDENTIFIED WITHOUT ANY ISSUE. ADDITIONALLY, THE E ANTIGENICITY OF THE CLAIMED LOT WAS COMPARED TO OTHER HOMOZYGOUS AND HETEROZYGOUS E ANTIGEN POSITIVE REAGENT RED BLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572396 ↗
• MalfunctionSep 14, 2022False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE ANTIBODY IDENTIFICATION ON IH-500 WITH IH PANEL 11 WAS INTERPRETED BY THE CUSTOMER AS A NOT PERFECTLY MATCHING ANTI-M. THE SAMPLE WAS SENT TO AN EXTERNAL LAG FOR CONFIRMATION OF THIS RESULT AND THERE AN ANTI-FYA WAS IDENTIFIED. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING BUT HE PROVIDED A PATIENT SAMPLE. THIS PATIENT SAMPLE COULD NOT BE TESTED AS IT WAS COMPLETELY HEMOLYZED. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DONOR SAMPLES ON THE IH-500. ALL RESULTS WERE CORRECT AND WERE ALSO INTERPRETED CORRECTLY BY THE SOFTWARE. A CHECK FO FHE AFFECTED IH-500 INSTRUMENT IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15416194 ↗
• MalfunctionFeb 28, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF A PATIENT SAMPLE WITH IH-PANEL 11 ON IH-1000. THE SPECIFICITY OF THE MISSED ANTIBODY WAS ANTI-E. ACCORDING TO THE ANTIGEN TABLE CELL #2 (EE) AND CELL #6 (EE) WERE SUPPOSED TO SHOW A POSITIVE REACTION. THE CUSTOMER STATED THAT THE SAMPLE WAS FROM A PREGNANT PATIENT AND THE TITER OF THE ANTI-E WAS <1, DETERMINED IN THE TUBE TEST. THE CUSTOMER DID NOT RETURN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT IH-PANEL 11 FOR INVESTIGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES AND ANTI-E ON IH-1000. ALL POSITIVE AND NEGATIVE REACTION WERE CORRECT. AN ANTI-E COULD BE CORRECTLY IDENTIFIED WITH IH-PANEL 11. 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-1000 INSTRUMENT DATA IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13617781 ↗
• MalfunctionApr 3, 2020False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result

  THE CUSTOMER REPORTED THAT A PATIENT SAMPLE WITH A KNOWN ANTI-C YIELDED A 3+ REACTION WHEN TESTED WITH DONOR #4 OF IH-PANEL 11. THE PANEL WAS RUN ON IH-500. THE ANTI-V OR ANTI-VS RESULT WAS YIELDED USING IMMUCOR CELLS IN PEG. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING.

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

  MAUDE report 9920941 ↗
• MalfunctionSep 11, 2018Incorrect, Inadequate or Imprecise Result or Readings

  ON AUGUST 14TH THE CUSTOMER REPORTED ABOUT A DISCORDANT TEST RESULT OF A SAMPLE DURING THE VALIDATION OF IH 1000, INVOLVING AN ANTI-FYA SPECIMEN . THE SCREEN OF THE PATIENT SAMPLE TESTED WITH ORTHO CELLS SHOWED POSITIVE RESULTS WITH HOMOZYGOUS CELLS (1+) AND HETEROZYGOTE CELLS (+/-) WHEREAS THE TESTING WITH BIO-RAD IH-PANEL CELLS YIELDED INTO NEGATIVE TEST RESULTS. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT (IH-PANEL 11/ LOT # 8823011) AND THE PATIENT SAMPLE WHICH HAD CAUSED THE DISCORDANT TEST RESULT. AT THE TIME THE COMPLAINT WAS REPORTED, THE EXPIRATION DATE OF THE PRODUCT WAS ALREADY EXCEEDED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. INVESTIGATION OF OUR QUALITY CONTROL LABORATORY IS STILL ONGOING.

  Patient problems: No Information

  MAUDE report 7863238 ↗
• MalfunctionSep 11, 2018Inaccurate Information

  ON (B)(6) THE CUSTOMER REPORTED ABOUT A DISCORDANT TEST RESULT OF A SAMPLE DURING THE VALIDATION OF IH 1000, INVOLVING AN ANTI-FYA . THE SCREEN OF THE PATIENT SAMPLE TESTED WITH ORTHO CELLS SHOWED POSITIVE RESULTS WITH HOMOZYGOUS CELLS (1+) AND HETEROZYGOTE CELLS (+/-) WHEREAS THE TESTING WITH BIO-RAD IH-PANEL CELLS YIELDED INTO NEGATIVE TEST RESULTS. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT (IH-PANEL 11/ LOT # 8819011) AND THE PATIENT SAMPLE WHICH HAD CAUSED THE DISCORDANT TEST RESULT. AT THE TIME THE COMPLAINT WAS REPORTED, THE EXPIRATION DATE OF THE PRODUCT WAS ALREADY EXCEEDED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. INVESTIGATION OF OUR QUALITY CONTROL LABORATORY IS STILL ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7863235 ↗