Erytype S ABO Confirm 806130100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611969965670), received between Jun 21, 2017 and Jun 11, 2018 — 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.

• MalfunctionJun 11, 2018False Positive Result; Defective Device

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF A DONOR SAMPLE WITH ANTI-B OF ERYTYPE S ABO CONFIRM WHEN USED ON TANGO INFINITY. THE CUSTOMER STATED THAT THE DONOR UNIT HAD BEEN TYPED AS BLOOD GROUP A AND THE SAMPLE WAS PROCESSED AFTER A PATIENT SAMPLE WITH BLOOD GROUP B. THE CUSTOMER WAS WONDERING IF THE PATIENT SAMPLE COULD HAVE AFFECTED THE DONOR SAMPLE. THE CUSTOMER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING AS WELL AS THE PATIENT SAMPLE AND THE DONOR SAMPLE. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE ERYTYPE S ABO CONFIRM ON TANGO INFINITY WITH DIFFERENT INTERNAL PATIENT SAMPLES AND THE SAMPLES PROVIDED BY THE CUSTOMER (PATIENT AND DONOR). ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT. ADDITIONAL TESTS WERE CARRIED OUT IN ORDER TO RULE OUT THAT THE PATIENT SAMPLE COULD HAVE AFFECTED THE DONOR SAMPLE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO INFINITY WAS INSPECTED BY A FIELD SERVICE ENGINEER AND FOUND TO WORK WITHIN SPECIFICATIONS. CUSTOMER CONTROLS ARE PASSING, AND THERE ARE NO HARDWARE ERRORS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7585711 ↗
• MalfunctionJun 21, 2017False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE REACTION OF ONE CONTROL WITH ANTI-B ON ERYTYPE S ABO CONFIRM WHEN USED ON TANGO INFINITY. THE CUSTOMER USED THE CONTROL REAGENTS (CONTROL 1, 2 AND 3) OF HEMOBIOSCIENCE. CONTROL 2 IS SUPPOSED TO BE BLOODGROUP O RH(D) POS, BUT IT YIELDED THE RESULT BLOODGROUP B RH(D) POS ON ERYTYPE S ABO CONFIRM ON TANGO INFINITY. AFTER CLEANING AND RINSING THE INSTRUMENT CUSTOMER REPEATED THE TESTING WITH THE SAME REAGENTS AND YIELDED CORRECT RESULTS. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT, BUT THE CONTROL THAT HAD CAUSED A FALSE POSITIVE TEST RESULT: CONTROL 1, 2 AND 3. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF ERYTYPE S ABO CONFIRM WITH THE CONTROLS ON TANGO INFINITY. THE CONTROLS REACTED AS EXPECTED. ADDITIONALLY THE RETENTION SAMPLE WAS TESTED WITH DIFFERENT POSITIVE AND NEGATIVE RED BLOOD CELLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S ABO CONFIRM FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6656150 ↗