IH-Card Rh-Phenotype+K 813201100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969952144), received between Mar 16, 2021 and Mar 16, 2021 — 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 16, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH THE ANTI-E OF IH-CARD RH-PHENOTYPE+K WHEN USED ON IH-1000. THE CUSTOMER STATED THAT THE REACTIONS WERE CALLED 1+ POSITIVE BY THE INSTRUMENT, BUT WERE VISUALLY NEGATIVE. THE CUSTOMER OBSERVED THIS ISSUE WHEN USING CELL #2 OF BIOTESTCELL 3 AS A CONTROL. THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE IH-CARD RH-PHENOTYPE+K FOR INVESTIGATIONAL TESTING NOR THE CONTROL THAT CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY (QC) TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THEIR RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, VISIBLE SUPERNATANT, AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES AND CONTROLS ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION OR QUESTION MARK RESULTS. FURTHERMORE THE IH-CARD RH-PHENOTYPE+K WAS TESTED WITH BIOTESTCELL 3. AN ORIGINAL VIAL OF CELL #2 (EE, E ANTIGEN NEGATIVE) OF B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492369 ↗
• MalfunctionMar 16, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE POSITIVE REACTIONS WITH THE ANTI-E OF IH-CARD RH-PHENOTYPE+K WHEN USED ON IH-1000. THE CUSTOMER STATED THAT THE REACTIONS WERE CALLED 1+ POSITIVE BY THE INSTRUMENT, BUT WERE VISUALLY NEGATIVE. THE CUSTOMER OBSERVED THIS ISSUE WHEN USING CELL #2 OF BIOTESTCELL 3 AS A CONTROL. THE CUSTOMER DID NEITHER RETURN THE COMPLAINT SAMPLE IH-CARD RH-PHENOTYPE+K FOR INVESTIGATIONAL TESTING NOR THE CONTROL THAT CAUSED THE FALSE POSITIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY (QC) TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. OUR QUALITY CONTROL LABORATORY VISUALLY INSPECTED THEIR RETENTION SAMPLE FOR INTACT SEALING, HOMOGENEOUS GEL, VISIBLE SUPERNATANT, AND THE ABSENCE OF SPLASHES IN THE REACTION CHAMBER. ALL ACCEPTANCE CRITERIA WERE MET. THEN OUR QUALITY CONTROL LABORATORY TESTED THE RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT DONOR SAMPLES AND CONTROLS ON THE IH-1000. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION OR QUESTION MARK RESULTS. FURTHERMORE THE IH-CARD RH-PHENOTYPE+K WAS TESTED WITH BIOTESTCELL 3. AN ORIGINAL VIAL OF CELL #2 (EE, E ANTIGEN NEGATIVE) OF B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492364 ↗