IH-Card Anti-D (DVI+) 813251100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611969962402), received between Aug 1, 2022 and Sep 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED WEAK POSITIVE RESULTS WITH THE ANTI-D INSTEAD OF CLEARLY NEGATIVE RESULTS ON IH-1000 WHEN USING THE IH-CARD ANTI-D (DVI+) . ORIGINALLY, THE CUSTOMER STATED THAT HE OBSERVED THIS ISSUE WITH HEMOBIOSCIENCE CONTROL QC3 WHICH IS SUPPOSED TO BE RHD NEGATIVE. THE CUSTOMER PROVIDED A PRODUCT SAMPLE OF THE AFFECTED IH-CARD ANTI-D (DVI+) FOR INVESTIGATIONAL TESTING . OUR QUALITY CONTROL LABORATORY IS CURRENTLY TESTING THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON IH-1000. THIS TESTING IS ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. ALSO STILL ONGOING IS AN ANALYSIS OF THE TRACE FILES OF THE AFFECTED INSTURMENT IH-1000.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354461 ↗
• MalfunctionSep 5, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED WEAK POSITIVE RESULTS WITH THE ANTI-D INSTEAD OF CLEARLY NEGATIVE RESULTS ON IH-1000 WHEN USING THE IH-CARD ANTI-D (DVI+) . ORIGINALLY, THE CUSTOMER STATED THAT HE OBSERVED THIS ISSUE WITH HEMOBIOSCIENCE CONTROL QC3 WHICH IS SUPPOSED TO BE RHD NEGATIVE. THE CUSTOMER PROVIDED A PRODUCT SAMPLE OF THE AFFECTED IH-CARD ANTI-D (DVI+) FOR INVESTIGATIONAL TESTING . OUR QUALITY CONTROL LABORATORY IS CURRENTLY TESTING THE COMPLAINT SAMPLE IN PARALLEL WITH THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT ON IH-1000. THIS TESTING IS ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. ALSO STILL ONGOING IS AN ANALYSIS OF THE TRACE FILES OF THE AFFECTED INSTRUMENT IH-1000.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354460 ↗
• MalfunctionAug 1, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED DRIED GEL COLUMNS IN POSITION 6 OF THE IH-CARD ANTI-D (DVI+) AND STATED THAT RESULTS OF KNOWN RHD NEGATIVE SAMPLES WERE WEAK POSITIVE ON THE IH-1000. THE CUSTOMER PROVIDED AN IMAGE OF AN UNPROCESSED CARD WHICH SHOWED A LOWER FILLING VOLUME IN COLUMN 6. ADDITIONALLY, THE CUSTOMER PROVIDED AN IMAGE OF THE DAILY JOURNAL THAT SHOWED A 1+ POSITIVE REACTION IN THE ANTI-D. THE IMAGE SHOWED A CLEARLY WEAK POSITIVE REACTION, BUT SIGNS OF DRYING WERE NOT VISIBLE IN THE AFFECTED GEL COLUMN. THE CUSTOMER RETURNED 87 IH-CARDS ANTI-D(DVI+) FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY VISUALLY CHECKED THEM FOR INTACT SEALING, HOMOGENEOUS GEL, VISIBLE SUPERNATANT, AND ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THE SUPERNATANT WAS REDUCED, BUT STILL VISIBLE. IT WAS KNOWN AND ACCEPTED THAT THE SUPERNATANT TOWARDS THE END OF THE SHELF LIFE WILL BE VERY, VERY SMALL. WITHIN OUR STABILITY STUDY WE COULD CONFIRM THAT THESE CARDS WORKED PROPERLY AND FULFILLED THE ACCEPTANCE CRITERIA. ADDITIONALLY, CARDS RETURNED BY THE CUSTOMER WERE TESTED WITH DONOR SAMPLES ON THE IH1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. A REVIEW OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137148 ↗