Solidscreen II Anti-D (RH1) Blend 806530100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611969951512), received between Aug 23, 2019 and Jun 19, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2020Output Problem; False Negative Result; Defective Device; Output Problem

  THE CUSTOMER REPORTED ABOUT FALSE NEGATIVE RESULT FOR WEAK D: TESTED AS INDETERMINATE FOR RHD ON THEIR PK ANALYZER AND WEAK D NEGATIVE ON THE TANGO INFINITY ON TWO DONORS. GENOMIC TESTING SHOWED THEM TO BE WEAK D VARIANTS. THE CUSTOMER COULD NOT PROVIDE RESULT IMAGES OF ORIGINAL TESTING DUE TO LENGTH OF TIME SINCE THE INSTANCES HAPPENED. THE LAST PREVENTATIVE MAINTENANCE ON THE AFFECTED TANGO INFINITY WAS CONDUCTED ON JANUARY 15, 2020. AFTER THE CUSTOMER FILED HIS COMPLAINT, A FIELD SERVICE ENGINEER CHECKED THE AFFECTED INSTRUMENT. THE ENGINEER WAS ON SITE TO COLLECT DATA AND VERIFY CAMERA SETTINGS. THE INSTRUMENT WAS CONFIRMED TO OPERATE WITHIN SPECIFICATIONS. THE LOG FILES ANALYSIS IS STILL ON-GOING. THE CUSTOMER RETURNED THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II (REF #806516100, LOT #8906080-05), BUT NOT THE SUPPOSEDLY DEFECTIVE PRODUCT SOLIDSCREEN II ANTI-D BLEND (REF # 806530100, LOT #8848040-01). THEREFORE OUR QUALITY CONTROL LABORATORY STARTED TESTING THEIR RETENTION SAMPLE OF SOLIDSCREEN II ANTI-D BLEND AND THE AHG PROVIDED BY CUSTOMER ON TANGO INFINITY. THIS TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING. A REVIEW OF THE BATCH RECORD DOCUMENTATION S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10173212 ↗
• MalfunctionJun 19, 2020Output Problem; False Negative Result; Defective Device; Output Problem

  THE CUSTOMER REPORTED ABOUT FALSE NEGATIVE RESULT FOR WEAK D: TESTED AS INDETERMINATE FOR RHD ON THEIR PK ANALYZER AND WEAK D NEGATIVE ON THE TANGO INFINITY ON TWO DONORS. GENOMIC TESTING SHOWED THEM TO BE WEAK D VARIANTS. AS PART OF INVESTIGATION FOR REPORT NO 9610824-2020-00032, THE CUSTOMER MENTIONED TWO OTHER OCCASIONS WHERE A DONOR TESTED AS INDETERMINATE FOR RHD ON THEIR PK ANALYZER AND WEAK D NEGATIVE ON THE TANGO INFINITY. SUBMITTING DONOR CENTERS REPORTED THAT GENOMIC TESTING ON THESE DONORS SHOWED THEM TO BE WEAK D VARIANTS. THE CUSTOMER DID NOT HAVE SAMPLES OR ACTUAL REPORTS REGARDING THE TYPE OF WEAK D THE GENOMIC TESTING RESULTED. THE CUSTOMER COULD NOT PROVIDE RESULT IMAGES OF ORIGINAL TESTING DUE TO LENGTH OF TIME SINCE THE INSTANCES HAPPENED. THE LAST PREVENTATIVE MAINTENANCE ON THE AFFECTED TANGO INFINITY WAS CONDUCTED ON JANUARY 15, 2020. AFTER THE CUSTOMER FILED HIS COMPLAINT, A FIELD SERVICE ENGINEER CHECKED THE AFFECTED INSTRUMENT. THE ENGINEER WAS ON SITE TO COLLECT DATA AND VERIFY CAMERA SETTINGS. THE INSTRUMENT WAS CONFIRMED TO OPERATE WITHIN SPECIFICATIONS. THE LOG FILES DID NOT SHOW ANY ISSUE RELEVANT ABNORMALITIES. THE WEAK D POSITIVE CONTROL REACTED MAIN

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

  MAUDE report 10173211 ↗
• MalfunctionJun 19, 2020Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ABOUT DISCREPANT WEAK D RESULTS ON ONE DONOR COMPARED TO PK INSTRUMENT: ON PK DEVICE RESULTED AS POSITIVE AND ON INFINITY AS NEGATIVE. GENOMIC TESTING GAVE A POSITIVE WEAK D. THE SUBMITTING DONOR CENTER SENT THE DONOR SAMPLE OUT FOR GENOMIC TESTING AND THE DONOR IS A WEAK D. THE CUSTOMER RETURNED THE SOLIDSCREEN II ANTI-D BLEND (REF #806530100, LOT #8913230-01), THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCREEN II (REF #806516100, LOT #8906080-05) AND SIX TUBES OF THE PATIENT SAMPLE #(B)(6) FOR INVESTIGATIONAL TESTING. THE CUSTOMER STATED THAT TWO TUBES EACH WERE PROCESSED ON TANGO INFINITY, THE PK INSTRUMENT AND THE PRISM INSTRUMENT. THE SAMPLES PROVIDED BY CUSTOMER WERE LABELED AS PK, TANGO AND PRISM. WE WOULD LIKE TO POINT OUT THAT THE SAMPLES LABELED AS TANGO AND PRISM WERE NATIVE SAMPLES AND THEREFORE NOT SUITED FOR THE PROCESSING ON THE TANGO INSTRUMENT. OUR QUALITY CONTROL LABORATORY ONLY TESTED THE SAMPLE LABELED AS PK IN THE WEAK D ASSAY ON THE TANGO INFINITY AND YIELDED A STRONGLY POSITIVE RESULT. PRIOR TO TESTING THE "PK SAMPLE" WAS WASHED FIVE TIMES WITH ISOTONIC SALINE DUE TO HEMOLYSIS. ADDITIONALLY THE ANTI-HUMAN GLOBULIN (AHG) ANTI-IGG SOLIDSCR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10173145 ↗
• MalfunctionAug 23, 2019False Positive Result; Defective Component

  THE CUSTOMER REPORTED A RHD DISCREPANCY OF ONE DONOR SAMPLE WHEN TESTED WITH SOLIDSCREEN II ANTI-D BLEND ON TANGO OPTIMO. THE CUSTOMER STATED THAT THE DONOR WAS KNOWN TO BE BLOOD GROUP O RHD NEGATIVE BUT YIELDED A POSITIVE RESULT WITH SOLIDSCREEN II ANTI-D BLEND ON TANGO OPTIMO. THE CUSTOMER STATED THAT THE DONOR UNIT SAMPLE WAS RETESTED ON THE TANGO OPTIMO AND THE RESULT WAS POSITIVE AGAIN. THE SAMPLE WAS ALSO TESTED MANUALLY AND RESULTED AS RHD NEGATIVE. THE CUSTOMER DID NOT RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT SOLIDSCREEN II ANTI-D BLEND FOR INVESTIGATIONAL TESTING BUT THE DONOR SAMPLE (LABELED AS (B)(6) ) THAT HAD CAUSED THE FALSE POSITIVE REACTION WITH SOLIDSCREEN II ANTI-D BLEND ON TANGO OPTIMO. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE DONOR UNIT SAMPLE WITH THEIR RETENTION SAMPLE OF SOLIDSCREEN II ANTI-D BLEND ON TANGO OPTIMO AND COULD CONFIRM THE CUSTOMER´S FINDING. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THE DONOR UNIT SAMPLE ON ERYTYPE S ABD+REV.A1, B AND YIELDED NEGATIVE RESULTS WITH BOTH ANTI-D REAGENTS. FURTHERMORE THE DONOR UNIT SAMPLE WAS TESTED MANUALLY WITH SERACLONE ANTI-D BLEND: THE IMMEDIATE SPIN METHOD AS WELL AS THE INDIRECT ANTIGLOBUL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8924316 ↗