IH-Card ABO/RhD(DVI+) 813131100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611969962341), received between Jun 23, 2021 and Mar 21, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2026False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE CONTROL WELL REACTIONS FOR 7 EDTA CORD BLOOD SAMPLES USING NEWBORN CARDS (PN 813131100, LOT 9521010, EXPIRY 9/21/2026) THAT WERE TESTED ON (B)(6) 2026. CUSTOMER RAN THE 7 EDTA CORD BLOOD SAMPLES WITH A NEW LOT OF NEWBORN CARDS (PN 813131100, LOT 9538010, EXPIRY 1/15/2027) AND GOT NEGATIVE RESULTS FOR THE CONTROL WELLS ON ALL 7 EDTA CORD BLOOD SAMPLES. CUSTOMER PERFORMED A RETROSPECTIVE REVIEW OF THEIR TESTING RESULTS. THE RETROSPECTIVE REVIEW SHOWED THAT SINCE NOVEMBER, THEY HAVE DOCUMENTED 192 CARDS WITH QUESTION MARKS ON CONTROL WELLS AND 47 CARDS WITH POSITIVE REACTIONS ON CONTROL WELLS ON NEWBORN CARDS LOT 9521010, EXPIRY 9/21/2026. THE TESTS WERE RUN ON THREE (B)(6) AND ON THE TWO (B)(6)'S. THESE NUMBERS DO NOT INCLUDE MANUALLY RUN CARDS, WHERE TECHS HAVE ALSO OBSERVED POSITIVE CONTROL WELLS. CUSTOMER HAS TRANSITIONED TO USING THE NEW LOT OF NEWBORN CARDS (LOT 9538010, EXPIRY 1/15/2027) AND HAVE QUARANTINE (B)(4) BOXES OF THE OLD LOT (LOT 9521010, EXPIRY 9/21/2026). CUSTOMER REPORTED THAT SEVERAL TECHS ALSO NOTED THAT THE FOIL ON NEWBORN CARD LOT 9521010, EXPIRY 9/21/2026 APPEARS TO PEEL MORE EASILY THAN USUAL UNLIKE THE NEW LOT OF NEWBORN CARD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656607 ↗
• MalfunctionOct 29, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED DISCREPANT DIRECT ANTIGLOBULIN TEST (DAT) RESULTS FOR FIVE NEONATAL SAMPLES TESTED BETWEEN SEPTEMBER 27, 2025, AND OCTOBER 20, 2025. THE BIRTHING HOSPITALS REPORTED POSITIVE DAT IGG RESULTS USING CORD BLOOD SAMPLES, WHILE SUBSEQUENT TESTING AT THE CUSTOMER FACILITY USING EDTA SAMPLES FROM THE SAME NEONATES YIELDED NEGATIVE RESULTS WITH BIO-RAD IH-CARD AHG ANTI-IGG (MANUAL GEL METHOD) AND TUBE TESTING. ALL AFFECTED NEONATES SUBSEQUENTLY DEVELOPED CLINICAL SIGNS OF HEMOLYTIC DISEASE OF THE NEWBORN (HDN) AND TESTED POSITIVE FOR MATERNAL ANTIBODIES. THE DISCREPANCY WAS FIRST BROUGHT TO THE CUSTOMER'S ATTENTION ON (B)(6) 2025, THOUGH ISSUES HAD BEEN OBSERVED AS EARLY AS ON (B)(6) 2025. THE FIRST FOUR SAMPLES (NEONATES 1-4, PLEASE SEE ALSO REPORT 9610824-2025-00035): BLOOD TYPES: ALL BABIES B POSITIVE, ALL MOTHERS O POSITIVE. CLINICAL PRESENTATION: ALL FOUR NEONATES TESTED POSITIVE FOR ANTI-B ANTIBODIES AND SHOWED CLINICAL SIGNS OF HDN. NO SAMPLES WERE AVAILABLE FOR INTERNAL TESTING (BABIES DISCHARGED). FIFTH SAMPLE (NEONATE 5, THIS REPORT): COLLECTION DATE: ON (B)(6) 2025. BLOOD TYPES: BABY A POSITIVE, MOTHER O POSITIVE. CLINICAL PRESENTATION: REPORTED BY CUSTOMER

  Patient problems: Hemolysis

  MAUDE report 23411578 ↗
• MalfunctionAug 28, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION ON THE ANTI-AB WELL WITH ONE PATIENT SAMPLE OF BLOOD GROUP O WHEN USING IH-CARD ABO/RHD (DVI+) ON THE IH-1000 INSTRUMENT. SAMPLE (B)(6) (TESTED ON (B)(6 )2024 ON IH-1000, S/N (B)(6) WAS 3+ FALSE POSITIV ON ANTI-AB WITH IH-CARD ABO/RHD (DVI+). THE SAMPLE WAS RE-TESTED ON THE SAME DAY, WITH THE SAME IH-CARD LOT AND ON THE SAME INSTRUMENT BUT ON THE OTHER SIDE OF THE IH-1000 AND REACTED NEGATIVE ON THE ANTI-AB. DUE TO THE INCONSISTENCY IN THE REACTIONS OBSERVED WITH ANTI-A AND ANTI-B (NEGATIVE), NO INCORRECT BLOOD GROUP TYPING WAS PERFORMED AT THE CUSTOMER'S LOCATION. THE CUSTOMER PROVIDED US WITH THE AFFECTED PATIENT SAMPLE AND ALSO RETURNED FOUR CARDS IH-CARD ABO/RHD (DVI+) LOT: 9337020 FOR INVESTIGATIONAL TESTING. AT FIRST OUR QUALITY CONTROL LABORATORY INVESTIGATED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT IH-CARD ABO/RHD (DVI+) AND THE CARDS THAT WERE PROVIDED BY THE CUSTOMER. THE VISUAL INSPECTION FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER WAS PASSED WITHOUT ANY IRREGULARITIES. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. THEN THE QUALITY CONTROL LABORAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20083245 ↗
• MalfunctionJun 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS OF TWO DIFFERENT PATIENT SAMPLES RUNNING CORD BLOOD USING 2 DIFFERENT INSTRUMENTATIONS AND 2 DIFFERENT TYPE TUBES ARE GIVING DISCREPANT RESULTS. CORD BLOOD (RED TOP) RAN ON THE IH-READER ON (B)(6) 2024, SAMPLE (B)(6) , DAT NEGATIVE. CORD BLOOD (RED TOP) RAN ON THE IH-READER ON (B)(6) 2024, SAMPLE (B)(6), DAT NEGATIVE. CORD BLOOD (PURPLE TOP) RAN ON IH-500 ON (B)(6) 2024, SAMPLE (B)(6) , DAT POSITIVE. CORD BLOOD (PURPLE TOP) RAN ON IH-500 ON (B)(6) 2024, SAMPLE (B)(6), DAT POSITIVE. IT WAS CURRENTLY UNKNOWN WHICH RESULT WAS CORRECT, THE POSITIVE DAT (DIRECT ANTIGLOBULIN TEST) OR THE NEGATIVE DAT (DIRECT ANTIGLOBULIN TEST). THE CUSTOMER DID NOT RETURN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING BUT TWO PATIENT SAMPLES. THE CUSTOMER PROVIDED IN THE PATIENT SAMPLES WITH PURPLE TOPS WHICH SHOWED POSITIVE DAT (DIRECT ANTIGLOBULIN TEST) RESULTS. THE CUSTOMER DID NOT RETURN THE PATIENT SAMPLES THAT YIELDED DAT NEGATIVE RESULTS. 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. INST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525979 ↗
• MalfunctionJun 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT RESULTS OF TWO DIFFERENT PATIENT SAMPLES. RUNNING CORD BLOOD USING 2 DIFFERENT INSTRUMENTATIONS AND 2 DIFFERENT TYPE TUBES ARE GIVING DISCREPANT RESULTS. CORD BLOOD (RED TOP) RAN ON THE IH-READER (B)(6) 2024, SAMPLE (B)(6), DAT NEGATIVE. CORD BLOOD (RED TOP) RAN ON THE IH-READER (B)(6) 2024, SAMPLE (B)(6), DAT NEGATIVE. CORD BLOOD (PURPLE TOP) RAN ON IH-500 (B)(6) 2024, SAMPLE (B)(6), DAT POSITIVE. CORD BLOOD (PURPLE TOP) RAN ON IH-500 (B)(6) 2024, SAMPLE (B)(6), DAT POSITIVE. IT WAS CURRENTLY UNKNOWN WHICH RESULT WAS CORRECT, THE POSITIVE DAT (DIRECT ANTIGLOBULIN TEST) OR THE NEGATIVE DAT (DIRECT ANTIGLOBULIN TEST). THE CUSTOMER DID NOT RETURN A PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING BUT TWO PATIENT SAMPLES. THE CUSTOMER PROVIDED IN THE PATIENT SAMPLES WITH PURPLE TOPS WHICH SHOWED POSITIVE DAT (DIRECT ANTIGLOBULIN TEST) RESULTS. THE CUSTOMER DID NOT RETURN THE PATIENT SAMPLES THAT YIELDED DAT NEGATIVE RESULTS. 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. INSTRUMENT DATA OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525978 ↗
• MalfunctionNov 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS OF IH-BASIC QC WITH IH-CARD ABO/RHD (DVI+) ON THEIR IH-500 INSTRUMENT. THE CUSTOMER STATED THAT THAT THEY RAN IH-BASIC QC 1 AND GOT AN AB RH(D) NEGATIVE RESULT IN THE FIRST RUN, AN AB RH(D) POSITIVE RESULT IN THE SECOND RUN, AND THE CORRECT A RH(D) NEGATIVE RESULT IN THE THIRD RUN. SHE STATED THAT ALSO ON OCTOBER 24, 2023, SHE GOT AN AB RH(D) POSITIVE RESULT IN THE FIRST RUN AND THE CORRECT A RH(D) NEGATIVE RESULT IN THE SECOND RUN. THE CUSTOMER STATED THAT ALL OTHER QC RUNS WERE CORRECT. THE CUSTOMER ANNOUNCED TO SEND IN A SAMPLE OF THE PRODUCT FOR INVESTIGATIONAL TESING. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE COMPLAINT MATERIAL OF THE CUSTOMER THEY TESTED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH IH-BASIC QC ON IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. ADDITIONALLY, OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THEIR RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. FURTHERMORE, ADD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18198493 ↗
• MalfunctionNov 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS OF IH-BASIC QC WITH IH-CARD ABO/RHD (DVI+) ON THEIR IH-500 INSTRUMENT. THE CUSTOMER STATED THAT THAT THEY RAN IH-BASIC QC 1 AND GOT AN AB RH(D) NEGATIVE RESULT IN THE FIRST RUN, AN AB RH(D) POSITIVE RESULT IN THE SECOND RUN, AND THE CORRECT A RH(D) NEGATIVE RESULT IN THE THIRD RUN. SHE STATED THAT ALSO ON (B)(6) 2023, SHE GOT AN AB RH(D) POSITIVE RESULT IN THE FIRST RUN AND THE CORRECT A RH(D) NEGATIVE RESULT IN THE SECOND RUN. THE CUSTOMER STATED THAT ALL OTHER QC RUNS WERE CORRECT. THE CUSTOMER ANNOUNCED TO SEND IN A SAMPLE OF THE PRODUCT FOR INVESTIGATIONAL TESING. WHILE OUR QUALITY CONTROL LABORATORY WAS WAITING FOR THE COMPLAINT MATERIAL OF THE CUSTOMER THEY TESTED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH IH-BASIC QC ON IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. ADDITIONALLY, OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THEIR RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. WE DID NOT OBSERVE ANY SPLASHES IN THE REACTION CHAMBER. FURTHERMORE, ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18198492 ↗
• MalfunctionJun 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER IS CURRENTLY VALIDATING THEIR INSTRUMENT IH-READER 24 AND REPORTS MANY QUESTIONABLE RESULTS. AS THE CUSTOMER SEES THIS ISSUE WITH DIFFERENT TYPES OF IH-CARDS, IN TOTAL FOUR (4) COMPLAINTS WERE INITIATED: (B)(6): IH-CARD ABO/RHD (DVI+) LOT: 8034020 (THE PRESENT CASE), (B)(6): IH-CARD ABD (DVI+)-CONF LOT: 8043080, (B)(6): IH-CARD AHG ANTI-IGG LOT: 8032010, (B)(6): IH-CARD ABO/D(DVI-)+REV A1,B LOT: 8009100. THE RESULTS WERE OBTAINED WITH THE IH-INTERNAL QC MATERIAL THAT EXPIRED ON MAY 31, 2021 (LOT: 780200102). AS THE MATERIAL WOULD HAVE NEVER REACHED DREIEICH BEFORE THE EXPIRATION DATE, NO SAMPLE MATERIAL COULD BE PROVIDED. FOR THE COMPLAINT INVESTIGATION OUR QUALITY CONTROL USED THE IH-INTERNAL QC LOT: 780200102 FROM QC STOCK AS WELL AS LOT: 780200103. BECAUSE NO SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT WAS PROVIDED BY THE CUSTOMER, OUR QUALITY LABORATORY TESTED THEIR RETENTION SAMPLE OF ABO/RHD (DVI+) LOT 8034020 WITH IH-LISS SOLUTION LOT: 76000.000007 AS USED AT THE CUSTOMER SITE. WE ATTEMPT TO REPRODUCE CUSTOMER CONCERNS THAT MORE QUESTIONABLE RESULTS ARE SEEN WHEN THE PIPETTED CARDS ARE NOT DIRECTLY INCUBATED/ CENTRIFUGED. THE CUSTOMER PROVIDED DAILY JOURNAL FOR IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048614 ↗