IH-Card ABD(DVI+)-Conf 813191100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07611969952137), received between Apr 3, 2019 and Nov 7, 2023 — classified as 6 malfunctions.

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

• MalfunctionNov 7, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED ABOUT TWO UNITS THAT WERE MISTYPED, BOTH WERE EXPECTED TO BE O RHD POSITIVE BUT WERE TYPED AS B RHD POSITIVE ON THE IH-1000, USING IH-CARD ABD(DVI+)-CONF. UPON RERUN, THE UNITS WERE CORRECTLY TYPED AS O RHD POSITIVE. THE IMAGES PROVIDED BY THE CUSTOMER SHOWED THE REPORTED POSITIVE REACTIONS IN THE ANTI-B WELL FOR TWO SAMPLES AND THE NEGATIVE REACTIONS UPON REPEAT. THE CUSTOMER DID NEITHER RETURN A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE AFFECTED PATIENT SAMPLES. AS THE PATIENT SAMPLE WERE EXHAUSTED AT CUSTOMER SITE, OUR QUALITY CONTROL COULD ONLY INVESTIGATE THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, THE RETENTION SAMPLE WAS CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. FOR THE SEROLOGICAL TEST ON THE IH-1000 INSTRUMENT, DIFFERENT DONOR SAMPLES WERE USED. THE FOCUS WAS ON O RHD POSITIVE AND A RHD POSITIVE SAMPLES AS THE CUSTOMER YIELDED FALSE POSITIVE RESULTS IN THE ANTI-B WELL. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. A REVIEW OF THE BATCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083581 ↗
• MalfunctionJan 24, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT EIGHT CONFIRMATION SAMPLES SHOWED FALSE POSITIVE RESULTS ON THE IH-CARD ABD(DVI+)-CONF WHEN USED ON THE IH-500. ALL SAMPLES CAME BACK AS BLOOD GROUP AB, BUT THE EXPECTED RESULTS WERE A POS, A NEG AND B POS. THE CUSTOMER STATED THAT FIVE OF THE EIGHT SAMPLES SHOWED CORRECT RESULTS WHEN RETESTED, WHILE THREE SAMPLES AGAIN SHOWED FALSE POSITIVE RESULTS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE CONFIRMATION SAMPLES THAT CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE, OUR QUALITY CONTROL IS TESTING THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON IH-500. THIS TESTING IS STILL ONGOING. WE ARE ALSO STIL WAITING FOR THE SNAP SHOTS AND TRACE FILES OF THE AFFECTED IH-500 FOR INVESTIGATION. DUE TO THE ONGOING INVESTIGATION, WE ARE NOT IN THE POSITION TO PROVIDE A CONCLUSIVE STATEMENT. 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 13334644 ↗
• MalfunctionJul 28, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH THE ANTI-B OF IH-CARD ABD(DVI+)-CONF. THE CUSTOMER STATED THAT DONOR SAMPLES OF THE BLOOD GROUP A WERE AFFECTED, AND THE ISSUE WAS OBSERVED IN THE MANUAL TESTING AND ON THE IH-500 INSTRUMENT. WHEN RE-TESTED, BOTH MANUALLY AND ON IH-500, THE SAMPLES SHOWED THE CORRECT BLOOD GROUP A. THE CUSTOMER DID NOT PROVIDE THE COMPLAINT SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTGATIONAL TESTING. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. ADDITIONALLY, THE RETENTION SAMPLE WAS VISUALLY CHECKED FOR INTACT SEALING, HOMOGENEOUS GEL, CORRECT FILLING HEIGHT AND THE PRESENCE OF SUPERNATANT. ALL ACCEPTANCE CRITERIA WERE MET. THE CUSTOMER SENT IN TWO DONOR SEGMENTS LABELED AS (B)(6) FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY TESTED THEM WITH THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON IH-500. BOTH PATIENT SAMPLES SHOWED THE CORRECT RESULTS: BLOOD GROUP A RH(D) POSITIVE.REGARDING THE AFFECTED IH-500: THE CUSTOMER PROVIDED PRINTOUTS OF THE DAILY JOURNAL W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12237803 ↗
• MalfunctionJun 8, 2021False Positive Result; False Positive Result

  THE CUSTOMER WAS VALIDATING THEIR INSTRUMENT IH-READER 24 AND REPORTING SEVERAL QUESTIONABLE RESULTS WITH DIFFERENTLY TYPES OF CARDS. AS THE CUSTOMER SAW THIS ISSUE WITH DIFFERENT TYPES OF IH-CARDS, IN TOTAL FOUR (4) COMPLAINTS WERE INITIATED: INV000079650: IH-CARD ABD (DVI+)-CONF LOT: 8043080 (THE PRESENT CASE). INV000079651: IH-CARD AHG ANTI-IGG LOT: 8032010. INV000079947: IH-CARD ABO/RHD (DVI+) LOT: 8034020. INV000079523: IH-CARD ABO/D(DVI-)+REV A1,B LOT: 8009100. A FIELD SERVICE ENGINEER CHECKED THE IH-READER 24. HE CLEANED THE CAMERA LENS AND LIGHTING FILTER. HE PERFORMED TECH TIP IH-023 AND PROCEEDED WITH PM DURING WHICH A FULL SYSTEM CHECKOUT WAS PERFORMED SUCCESSFULLY. A CALIBRATION WAS PERFORMED AND PASSED. THE QC WAS PERFORMED WITH NO IRREGULARITIES. THE SCREENSHOTS THE CUSTOMER PROVIDED LOOKED FINE BASED ON VALUE ADJUSTMENTS AND AZIMUTH. THE CUSTOMER HAS NOT BEEN ABLE TO PERFORM ANY ADDITIONAL TESTING DUE TO STAFFING SHORTAGES. THE PROVIDED DAILY JOURNAL SHOWED THAT USING THE IH-INTERNAL QC SAMPLE 2, THAT IS EXPECTED TO BE O RHD NEGATIVE, THE IH-COM GRADED VISUALLY CLEAR NEGATIVE REACTIONS IN THE ANTI-A AS WELL AS ANTI-B WELL WITH A "NOT INTERPRETABLE (1+)" RESULT. FOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11956039 ↗
• MalfunctionJan 22, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE RESULTS IH-CARD ABD (DVI+)-CONF ON IH-500. THE CUSTOMER ALSO REPORTED SOME TECHNICAL ISSUES AND A PIPETTOR ERROR MESSAGE. SHE DID NOT PROVIDE A DATE OF EVENT. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE LOT FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT CAUSED FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES AND CONTROLS ON IH-500. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE INVESTIGATION OF THE INSTRUMENT DATA IS STILL ONGOING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214596 ↗
• MalfunctionApr 3, 2019False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result

  THE CUSTOMER REPORTED THAT A UNIT WAS TYPED AS B RH(D) NEGATIVE WHEN USING IH-CARD ABD (DVI+) CONF. ON IH-1000. THIS UNIT WAS LABELLED AS O RH(D) NEGATIVE. THE BLOOD GROUP O WAS CONFIRMED IN A MANUAL TEST METHOD. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT. OUR QUALITY CONTROL LABORATORY IS STILL TESTING THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT. INVESTIGATION OF THE PROVIDED INSTRUMENT DOCUMENTATION 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; No Known Impact Or Consequence To Patient

  MAUDE report 8477710 ↗