IH-Card ABO/D(DVI+)+Rev A1,B 813122100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969964543), received between Oct 8, 2020 and Mar 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A PATIENT SAMPLE (NO (B)(6)) WITH ANTI-B OF IH-CARD ABO/D(DV+) +REV. A1, B ON THE IH-1000 INSTRUMENT. THE CUSTOMER STATED THAT THE PATIENT SAMPLE IN QUESTION HAD THE BLOOD GROUP O RHD POSITIVE AND THAT THE PATIENT SAMPLE SHOWED THE CORRECT BLOOD GROUP IN A RETEST WITH THE SAME LOT OF IH-CARD ABO(DVI+) + REV. A1, B ON THE IH-1000. THE CUSTOMER DID NOT PROVIDE A SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING BUT SHE PROVIDED THE PATIENT SAMPLE THAT CAUSED THE FALSE POSITIVE TEST RESULT. FIRST, OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT 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 OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE WITH DIFFERENT DONOR SAMPLES ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION IN THE ANTI-B WELL. DUE TO THE SMALL QUANTITY OF THE PATIENT SAMPLE AND THE BAD STATUS OF IT, THE PATIENT SAMPLE COULD NOT BE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589734 ↗
• MalfunctionOct 8, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A RHD DISCREPANCY OF ONE PATIENT SAMPLE DURING HER VALIDATION ACTIVITIES WITH THE IH-READER 24. THE PATIENT SAMPLE WAS TESTED IN THE IH-CARD ABO/D(DVI+)+REV.A1, B AND THE ANTI-D (VI+) YIELDED A STRONG POSITIVE RESULT. THE SAMPLE WAS ALSO TESTED IN THE ABD CARD OF A COMPETITOR AND THE TUBE TEST AND YIELDED NEGATIVE RESULTS. THE CUSTOMER DID NOT RETURN THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING, BUT THE PATIENT SAMPLE (B)(6) THAT HAD CAUSED THE DISCREPANCY. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT AND COULD CONFIRM THE CUSTOMER´S FINDING: THE SAMPLE YIELDED A 4+ POSITIVE REACTION WITH THE ANTI-D(VI+). THE PATIENT SAMPLE WAS ALSO TESTED ON THE IH-CARD ABD(DVI-) AND YIELDED A NEGATIVE RESULT WITH THE ANTI-D(VI-). ADDITIONALLY THE PATIENT SAMPLE WAS TESTED FOR RHD IN THE TUBE TECHNIQUE AND YIELDED A POSITIVE RESULT ONLY IN THE INDIRECT ANTIGLOBULIN TEST (IAT) WITH SERACLONE ANTI-D BLEND. ADDITIONALLY THE RETENTION SAMPLE WAS TESTED WITH DIFFERENT DONOR SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. BASED ON THE SEROLOGICAL TEST RESULTS THE RH(D) FACTOR OF THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10647414 ↗