IH-Card ABO/D(DVI-)+Rev A1,B 813111100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07611969952090), received between Nov 13, 2019 and Jun 26, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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.

• MalfunctionJun 26, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF PATIENT AND QC SAMPLES WITH THE ANTI-B AND THE CONTROL WELL OF IH-CARD ABO/D(DVI-)+REV. A1, B. DURING MANUAL TESTING IT WAS ALSO NOTICED THAT SPLASHES OF ANTI-A WERE FOUND BESIDES THE ANTI-A COLUMNS. THE CUSTOMER SAID SHE RECEIVED ALL THE BOXES IN ONE SHIPMENT. OUR QUALITY CONTROL LABORATORY INVESTIGATED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. FIRST, OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THE 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. THEN THE QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES IN THE MANUAL TEST METHOD. AS THE REASON FOR THE COMPLAINT WERE FALSE POSITIVE REACTIONS IN THE ANTI-B, THE FOCUS WAS ON THE TESTING OF BLOOD GROUP A AND O SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION IN THE ANTI-B OR CONTROL WELL WITH THE RETENTION SAMPLE. THE CUSTOMER SENT IN 75 IH-CARD ABO/D(DVI-)+REV A1,B OF THE AFFECTED LOT FOR INVESTIGATIONAL TESTING. WE IDEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611965 ↗
• MalfunctionAug 5, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT REACTIONS WITH THE ANTI-D OF IH-CARD ABO/D(DVI-)+REV A1,B WERE WEAKLY FALSE POSITIVE RESPECTIVELY QUESTION MARK. THE RESULTS WERE SUPPOSED TO BE NEGATIVE. THE CUSTOMER WORKED MANUALLY USING IH-READER 24. THE CUSTOMER ANNOUNCED TO SHIPF THE COMPLAINT SAMPLE IH-CARD ABO/D(DVI-)+REV. A1, B (REF #(B)(4), LOT 9145030, EXP. 2023-03-12) FOR INVESTIGATIONAL TESTING. WE ARE STILL WAITING FOR THIS SAMPLE TO ARRIVE ON OUR PREMISES. THE INVESTIGATION OF THE RETENTION SAMPLE IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. DATA FILES OF THE AFFECTED IH-READER WERE REQUESTED FOR ANALYSIS. WE ARE STILL WAITING FOR THESE FILES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174652 ↗
• MalfunctionJun 7, 2021False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER WAS VALIDATING THEIR INSTRUMENT IH-READER 24 AND REPORTED MANY 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: INV000079523: IH-CARD ABO/D(DVI-)+REV A1,B LOT: 8009100 (THE PRESENT CASE). INV000079650: IH-CARD ABD (DVI+)-CONF LOT: 8043080. INV000079651: IH-CARD AHG ANTI-IGG LOT: 8032010. INV000079947: IH-CARD ABO/RHD (DVI+) LOT: 8034020. 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 THE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946316 ↗
• MalfunctionSep 3, 2020False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE TEST RESULT OF IH-CARD ABO/D(DVI-)+REV A1,B WHEN USED ON IH-1000. THE ANTI-A WAS INTERPRETED AS 1+ BUT VISUALLY APPEARED TO BE COMPLETELY NEGATIVE. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED, "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULT WAS RELEASED. TESTING WAS REPEATED AT THE MANUAL BENCH WITH THE TUBE TEST USING THE DEVICE OF A COMPETITOR AND YIELDED A NEGATIVE TEST RESULT. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT IH-CARD ABO/D(DVI-)+REV A1,B FOR INVESTIGATIONAL TESTING NOR THE AFFECTED PATIENT SAMPLE. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT IH-CARD ABO/D(DVI-)+REV A1,B WITH DIFFERENT DONOR SAMPLES AND WITH THE FOCUS ON A ANTIGEN NEGATIVE DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE GRADED REACTION. THE CUSTOMER PROVIDED ONE RESULT IMAGE THAT CONFIRMED THE FALSE POSITIVE GRADED RESULT. ACCORDING TO THE TRACE FIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10487156 ↗
• MalfunctionApr 3, 2020False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REVERSE CELL AND IGG CARD REACTIONS WHEN USING IH-CARD ABO/D(DVI-)+REV. A1,B ON IH-500. THE INSTRUMENT INTERPRETED THE RESULT AS "ABO TYPE NOT DETERMINED". THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING, BUT TWO (2) SAMPLES THAT HAD CAUSED THE FALSE POSITIVE REACTIONS IN THE REVERSE TYPING. UNFORTUNATELY, WE COULD NOT ANALYZE THE TRACE FILES OF THE IH-500 SINCE THEY WERE NOT PROVIDED FOR THE REQUIRED TEST DATE. FURTHERMORE, THE REAGENT RED BLOOD CELL (RRBC) LOTS USED AT CUSTOMER SITE WERE EXPIRED AT THE TIME THE SAMPLES WERE TESTED, SO FOR THE COMPLAINT INVESTIGATION ALTERNATE IN-DATE RRBCS WERE USED. OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT IH-CARD ABO/D(DVI-)+REV A1,B WITH DIFFERENT DONOR ON IH-500. THE RESULTS OBTAINED ON THE REVERSE GROUPING WERE ALL CORRECT AND CONCORDANT WITH THE FORWARD GROUPING. WE DID NOT OBSERVE ANY FALSE POSITIVE GRADED REACTION. SUBSEQUENTLY, THE TWO (2) AFFECTED PATIENT SAMPLES WERE CENTRIFUGED AT 2000 G FOR 10 MINUTES BEFORE TESTING AS RECOMMENDED IN THE INSTRUCTION FOR USE. TESTING OF ONE (1) SAMPLE WAS PERFORMED FULLY

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

  MAUDE report 9921032 ↗
• MalfunctionNov 13, 2019False Negative Result; False Negative Result; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED ONE UNEXPECTED NEGATIVE REACTION WITH IH-CELL B IN THE REVERSE GROUPING OF IH-CARD ABO/D(DVI-) WHEN USED ON THE IH-1000 INSTRUMENT. THE RESULT WAS EXPECTED TO BE POSITIVE. THE PATIENT SAMPLE THAT CAUSED THE FALSE NEGATIVE TEST RESULT WAS NOT AVAILABLE FOR INVESTIGATION. BUT THE CUSTOMER RETURNED THE IH-1000 FILES. THE IMAGE OF THE FALSE NEGATIVE REACTION APPEARED TO BE A DOUBLE POPULATION (DP) WITH FIBRIN ON TOP AND THROUGH THE GEL, BUT THE INTERPRETATION WAS NEGATIVE. BASED ON THE INVESTIGATION OF THE INSTRUMENT FILES THE COMPLAINT WAS CLASSIFIED AS CONFIRMED - EPP. IT SEEMED THAT THE RESULT WAS NEGATIVE DUE TO A PATIENT WITH WEAK ISOAGGLUTININ. THE INTERPRETATION WAS LINKED TO THE ALGORITHM IMAGE ANALYSIS AND WAS IN THE SPECIFICATIONS OF THIS TEST. A MALFUNCTION OF THE INSTRUMENT WAS EXCLUDED. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED, "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. THE PATIENT SAMPLE AFFECTED WAS NOT AVAILABLE FOR TESTING. HOWEVER, WE WOULD LIKE TO REFER TO THE CHAPTER LIMITATIONS OF THE IFU (INSTRUCTION FOR USE), WHERE IT IS STATED: "DECREASED ABO ANTIBODY REACTIVITY MAY BE SEEN WITH LOW T

  Patient problems: No Clinical Signs, Symptoms or Conditions; Reaction

  MAUDE report 9313827 ↗