IH-Card ABD(DVI-)-Conf 813181100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611969952120), received between Sep 3, 2020 and Sep 29, 2023 — 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 29, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF CORD BLOOD SAMPLES WITH THE ANTI-B OF IH-CARD ABD(DVI-)-CONF ON THEIR IH-500 INSTRUMENT. THE CUSTOMER STATED THAT THEY RECEIVED CORRECT RESULTS IN THE TUBE TEST. THE CUSTOMER ANNOUNCED TO SEND IN THE COMPLAINT SAMPLE IH-CARD ABD(DVI-)-CONF FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY HAS NOT YET STARTED TESTING BUT IS WAITING FOR THE COMPLAINT MATERIAL OF THE CUSTOMER. INSTRUMENT DATE OF THE AFFECTED IH-500 WERE REQUESTED AND THE INVESTIGATION OF THE RECEIVED DATABASES IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17845525 ↗
• MalfunctionSep 29, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS OF CORD BLOOD SAMPLES WITH THE ANTI-B OF (B)(6) ON THEIR IH-500 INSTRUMENT. THE CUSTOMER STATED THAT THEY RECEIVED CORRECT RESULTS IN THE TUBE TEST. THE CUSTOMER ANNOUNCED TO SEND IN THE COMPLAINT SAMPLE (B)(6) FOR INVESTIGATIONAL TESTING. OUR QUALITY CONTROL LABORATORY HAS NOT YET STARTED TESTING BUT IS WAITING FOR THE COMPLAINT MATERIAL OF THE CUSTOMER. INSTRUMENT DATE OF THE AFFECTED IH-500 WERE REQUESTED AND THE INVESTIGATION OF THE RECEIVED DATABASES IS STILL ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17845516 ↗
• MalfunctionSep 3, 2020False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result

  THE CUSTOMER REPORTED SEVERAL ISSUES WITH FALSE POSITIVE RESULTS INVOLVING IH-CARD ABD(DVI-)-CONF ON THE IH-1000. THE CUSTOMER STATED THAT THE SOFTWARE INTERPRETATION WAS 1+ POSITIVE, WHEN THE IMAGES WERE CLEARLY NEGATIVE. THE CUSTOMER DID NEITHER RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY CHECKED THEIR RETENTION SAMPLE OF THE ALLEGEDLY DEFECTIVE PRODUCT LOT VISUALLY AND ALL ACCEPTANCE CRITERIA WERE MET. THE SPECIFICATIONS WERE: VISIBLE SUPERNATANT HOMOGENEOUS GEL INTACT SEALING NO SPLASHES IN THE REACTION CHAMBER FURTHERMORE, SEVERAL CARDS OF THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE PRODUCT IH-CARD ABD(DVI-)-CONF WERE TESTED WITH DONOR SAMPLES ON IH-1000. NO FALSE POSITIVE REACTIONS WERE OBSERVED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. ACCORDING TO OUR SOP THE COMPLAINT WAS CLASSIFIED AS UNDETERMINED: THE COMPLAINT SAMPLE WAS NOT AVAILABLE, AND THE RETENTION SAMPLE REACTED AS EXPECTED. THE CUSTOMER PROVIDED IMAGES, BUT NOT FOR THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10487283 ↗