IH-Card ABO/D(DVI+)+Rev A1,B 813121100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969952106), received between Nov 7, 2019 and Apr 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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.

• MalfunctionApr 14, 2020False Positive Result; Defective Device

  THE CUSTOMER REPORTED A FALSE POSITIVE RESULT OF ONE PATIENT SAMPLE ((B)(6)) WITH THE ANTI-B AND THE CONTROL OF THE IH-CARD ABO/D(DVI+)+REV.A1, B ON IH-1000 (B)(4). THE CUSTOMER STATED THAT THE MANUAL TESTING WITH THE SAME CARD LOT AND SAME SPECIMEN YIELDED A CORRECT RESULT. DUE TO THE DISCREPANCY BETWEEN FORWARD AND REVERSE TYPING AND THE FALSE POSITIVE REACTION WITH THE CONTROL THE IH-1000 STATED "A DISCREPANCY HAS BEEN IDENTIFIED" AND NO INCORRECT RESULT WAS RELEASED. WITHIN THE INVESTIGATION OF THE TRACE FILES WE BECAME AWARE THAT ANOTHER SAMPLE SHOWED A SIMILAR ISSUE ON (B)(6) 2020: SAMPLE (B)(6) SHOWED A FALSE POSITIVE RESULT WITH THE ANTI-B AND THE CONTROL OF THE IH-CARD ABO/D(DVI+)+REV.A1, B LOT 8924050 ON IH-1000 (B)(4). THE CUSTOMER RETURNED TRACE FILES FOR INVESTIGATION, BUT NEITHER THE COMPLAINT SAMPLES OF THE SUPPOSEDLY DEFECTIVE PRODUCTS NOR THE PATIENT SAMPLES THAT HAD CAUSED THE FALSE POSITIVE RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLES OF BOTH SUPPOSEDLY DEFECTIVE LOTS WITH DIFFERENT DONOR SAMPLES ON IH-1000. ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. THE TRACES FILES OF THE A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9956843 ↗
• MalfunctionNov 7, 2019False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE PATIENT SAMPLE WITH ANTI-B OF IH-CARD ABO/D(DVI-) +REV A1, B ON IH-1000. THE CUSTOMER STATED THAT A PATIENT FROM WITH A KNOWN BLOOD GROUP B RHD NEGATIVE WAS TRANSFERRED FROM ANOTHER HOSPITAL. THE PATIENT RECEIVED TWO UNITS OF BLOOD GROUP O RHD NEGATIVE BLOOD BEFORE ARRIVING AT THE HOSPITAL. WHEN THE PATIENT ARRIVED A TYPE AND SCREEN WAS ORDERED AND PERFORMED WITH IH-CARD ABO/D(DVI-) +REV A1, B ON IH-1000. THE PATIENT SAMPLE WAS DRAWN RIGHT AFTER THE TRANSFUSION. THE PATIENT SAMPLE WAS FORWARD TYPED AS BLOOD GROUP O RHD NEGATIVE WITH NEGATIVE REACTIONS IN THE ANTI-A, ANTI-B, ANTI-D AND THE CONTROL WELLS, BUT REVERSE TYPED AS A BLOOD GROUP B. ADDITIONALLY THE SAME PATIENT SAMPLE WAS TESTED MANUALLY WITH THE SAME LOT OF IH-CARD ABO/D(DVI-) +REV A1, B AND REACTED CORRECTLY AS BLOOD GROUP B WITH A 4+ REACTION IN THE ANTI-B. NEITHER THERE WAS ANY DOUBLE POPULATION (DP) ON THE MANUAL GEL RESULTS. UNFORTUNATELY, WE COULD NOT ANALYSE THE TRACE FILES FOR THE IH-1000 SINCE WE DID NOT RECEIVE THEM FOR THE REQUIRED TEST DATE. THE CUSTOMER PROVIDED US THE RESULT IMAGE WHICH CONFIRMED THE FALSE NEGATIVE REACTION IN WELL ANTI-B. THIS IMAGE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions; Reaction

  MAUDE report 9289320 ↗