IH-Card ABD(DVI-)-Conf 813182100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07611969964604), received between Nov 20, 2019 and Nov 20, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “False Negative 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2019False Negative Result

  THE CUSTOMER MADE A GENERAL COMPLAINT DURING A MEETING AT THE AABB CONVENTION IN 2019 AND REPORTED ABO DISCREPANCIES ON IH-1000. THE CUSTOMER STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE, THE CUSTOMER STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. THE CUSTOMER HAS OBSERVED THIS ISSUE WITH SINGLE PATIENT SAMPLES SINCE JULY 2019 BUT VOICED HIS COMPLAINED ONLY IN OCTOBER 2019 . THE CUSTOMER PROVIDED IH-1000 IMAGES OF SIX SPECIMENS WHICH CONFIRMED THE FALSE NEGATIVE REACTIONS IN THE REVERSE TYPING. THESE SIX SAMPLES WERE TESTED ON JULY13 (ONE SPECIMEN), JULY 15 (ONE SPECIMEN), JULY 18 (ONE SPECIMEN), JULY 22 (TWO SPECIMEN) AND JULY 24 (ONE SPECIMEN), 2019. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. BECAUSE OF THE TIME LAPSE BETWEEN OBSERVING THESE FALSE NEGATIVE REAGCTIONS AND FILING HIS COMPLAINT, THE CUSTOMER WAS NOT ABLE TO RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT, THE AFFECTED PATIENT DONOR SAMPLES THAT HAD REACTED FALSE NEGATIVE IN REVERSE TYPING AS WELL AS THE NEEDED TRACE FILES FOR FURTHER INVEST

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

  MAUDE report 9346457 ↗
• MalfunctionNov 20, 2019False Negative Result

  THE CUSTOMER MADE A GENERAL COMPLAINT DURING A MEETING AT THE RECENT (B)(6) CONVENTION. THE CUSTOMER REPORTED ABO DISCREPANCIES ON IH-1000. HE STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE HE STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. THE CUSTOMER HAS BEEN OBSERVING THIS ISSUE ON SINGLE PATIENT SAMPLES SINCE (B)(6), BUT JUST MENTIONED THIS ISSUE DURING THE (B)(6) ON (B)(6) 2019. THE CUSTOMER PROVIDED IH-1000 IMAGES OF SIX SPECIMENS WHICH HAD CAUSED ALLEGEDLY FALSE NEGATIVE REACTIONS IN THE REVERSE TYPING. THESE SIX SAMPLES WERE TESTED ON (B)(6) (ONE SPECIMEN), (B)(6) (ONE SPECIMEN), (B)(6) (ONE SPECIMEN), (B)(6) (TWO SPECIMEN) AND (B)(6) (ONE SPECIMEN), (B)(6). WE ARE STILL TRYING TO GET ALL MISSING INFORMATION LIKE E.G. LOT NUMBER AND CONCOMITANT PRODUCTS FROM THE CUSTOMER.

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

  MAUDE report 9346456 ↗
• MalfunctionNov 20, 2019False Negative Result

  THE CUSTOMER MADE A GENERAL COMPLAINT DURING A MEETING AT THE AABB CONVENTION IN 2019 AND REPORTED ABO DISCREPANCIES ON IH-1000. THE CUSTOMER STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE, THE CUSTOMER STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. THE CUSTOMER HAS OBSERVED THIS ISSUE WITH SINGLE PATIENT SAMPLES SINCE (B)(6) 2019 BUT VOICED HIS COMPLAINED ONLY IN (B)(6) 2019 . THE CUSTOMER PROVIDED IH-1000 IMAGES OF SIX SPECIMENS WHICH CONFIRMED THE FALSE NEGATIVE REACTIONS IN THE REVERSE TYPING. THESE SIX SAMPLES WERE TESTED ON (B)(6) (ONE SPECIMEN), (B)(6) (ONE SPECIMEN), (B)(6) (ONE SPECIMEN), (B)(6) (TWO SPECIMEN) AND (B)(6) (ONE SPECIMEN), 2019. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. BECAUSE OF THE TIME LAPSE BETWEEN OBSERVING THESE FALSE NEGATIVE REAGCTIONS AND FILING HIS COMPLAINT, THE CUSTOMER WAS NOT ABLE TO RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT, THE AFFECTED PATIENT DONOR SAMPLES THAT HAD REACTED FALSE NEGATIVE IN REVERSE TYPING AS WELL AS THE NEEDED TRACE FILES FOR FURTHER INVESTIGA

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

  MAUDE report 9346455 ↗
• MalfunctionNov 20, 2019False Negative Result

  THE CUSTOMER MADE A GENERAL COMPLAINT DURING A MEETING AT THE AABB CONVENTION IN 2019 AND REPORTED ABO DISCREPANCIES ON IH-1000. THE CUSTOMER STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE, THE CUSTOMER STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. THE CUSTOMER HAS OBSERVED THIS ISSUE WITH SINGLE PATIENT SAMPLES SINCE (B)(6) 2019 BUT VOICED HIS COMPLAINED ONLY IN OCTOBER 2019 . THE CUSTOMER PROVIDED IH-1000 IMAGES OF SIX SPECIMENS WHICH CONFIRMED THE FALSE NEGATIVE REACTIONS IN THE REVERSE TYPING. THESE SIX SAMPLES WERE TESTED ON (B)(6) (ONE SPECIMEN), (B)(6) (ONE SPECIMEN), (B)(6) (ONE SPECIMEN), (B)(6) (TWO SPECIMEN) AND (B)(6) (ONE SPECIMEN), 2019. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING THE IH-1000 STATED "ABO NOT INTERPRETABLE" AND NO INCORRECT RESULTS WERE RELEASED. BECAUSE OF THE TIME LAPSE BETWEEN OBSERVING THESE FALSE NEGATIVE REACTIONS AND FILING HIS COMPLAINT, THE CUSTOMER WAS NOT ABLE TO RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT, THE AFFECTED PATIENT DONOR SAMPLES THAT HAD REACTED FALSE NEGATIVE IN REVERSE TYPING AS WELL AS THE NEEDED TRACE FILES FOR FURTHER INVESTIGA

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

  MAUDE report 9346454 ↗
• MalfunctionNov 20, 2019False Negative Result

  THE CUSTOMER MADE A GENERAL COMPLAINT DURING A MEETING AT THE RECENT AABB CONVENTION. THE CUSTOMER REPORTED ABO DISCREPANCIES ON IH-1000. HE STATED THAT ONE OF THE WELLS OF THE BACK TYPE HAD NO REACTION WHEN A POSITIVE REACTION WAS EXPECTED. FURTHERMORE HE STATED THAT THE REACTIONS WERE CORRECTLY POSITIVE IN THE TUBE TEST. THE CUSTOMER HAS BEEN OBSERVING THIS ISSUE ON SINGLE PATIENT SAMPLES SINCE (B)(6), BUT JUST MENTIONED THIS ISSUE DURING THE AABB ON (B)(6) 2019. THE CUSTOMER PROVIDED IH-1000 IMAGES OF SIX SPECIMENS WHICH HAD CAUSED ALLEGEDLY FALSE NEGATIVE REACTIONS IN THE REVERSE TYPING. THESE SIX SAMPLES WERE TESTED ON (B)(6) (ONE SPECIMEN), (B)(6) (ONE SPECIMEN), (B)(6) (ONE SPECIMEN), (B)(6) (TWO SPECIMEN) AND (B)(6) (ONE SPECIMEN), 2019. WE ARE STILL TRYING TO GET ALL MISSING INFORMATION LIKE E.G. LOT NUMBER AND CONCOMITANT PRODUCTS FROM THE CUSTOMER.

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

  MAUDE report 9346453 ↗