Factor VIII Antibody Screen F8SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888234500001), received between Jul 20, 2018 and Jul 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER COMPLAINT (B)(4) WAS RECEIVED ON (B)(6) 2017 FOR FACTOR VIII ANTIBODY SCREEN (303283) LOT 3004682. THE CUSTOMER REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT HAD FACTOR VIII ANTIBODY SCREEN ASSAY RESULTS THAT WERE NEGATIVE, AND THE LABORATORY'S BETHESDA ASSAY RESULTS WERE POSITIVE (2.4 TITER). FACTOR VII ANTIBODY SCREEN ASSAY RESULTS ARE ALSO DEPENDENT ON THE PROGRESSION OF ANTIBODY FORMATION AS WELL AS IF/WHEN FVIII THERAPY IS ADMINISTERED. THE PATIENT'S COURSE OF THERAPY WAS NOT AVAILABLE FROM THE LABORATORY.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 7706639 ↗