Solidscreen II Strip 806521100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611969951499), received between Oct 8, 2020 and Oct 8, 2020 — classified as 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED THAT A VISUALLY POSITIVE DIRECT ANTI-GLOBULIN TEST (DAT) WITH SOLIDSCREEN II STRIP WAS CALLED NEGATIVE BY TWO TANGO INFINITY INSTRUMENTS. THE CUSTOMER DID NEITHER PROVIDE THE COMPLAINT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE SAMPLES THAT HAD CAUSED FALSE NEGATIVE TEST RESULTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF SOLIDSCREEN II ON TANGO INFINITY. WE PERFORMED THE ANTIBODY SCREENING TEST WITH BIOTESTCELL 3 AND A DIRECT ANTIGLOBULIN TEST (DAT). ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. ADDITIONALLY OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE AHG ANTI-IGG SOLIDSCREEN II LOT THE CUSTOMER HAD USED FOR POTENCY. AGAIN, ALL ACCEPTANCE CRITERIA WERE MET. THE CUSTOMER DID PROVIDE RESULT IMAGES THAT SHOWS A DIFFUSE CELL BUTTON, BUT BRIGHT BOARDER OF THE WELL INDICATING A BIG DIFFERENCE IN COLOR BETWEEN THOSE, ENABLING THE INSTRUMENTS IMAGE INTERPRETATION SOFTWARE TO CALCULATE THE RESULT AS NEGATIVE. UPON VISUAL INSPECTION THE CUSTOMER MAY EDIT THE RESULT TO A +/- REACTION, NOT 1+. NO LAST PREVENTATIVE MAINTENANCE DATE IS AVAILABLE BECAUSE THE INSTRUMENTS IN QUESTION ARE NEW INSTRUMENTS IN THEIR PHASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10648564 ↗