Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

What the Data Shows About Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

The FDA MAUDE database aggregates 507 adverse-event reports for Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations spanning the period from 2019 through 2026. Of these, 0 are classified as death reports, 125 as injury reports, and 382 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 2 distinct event types and 2 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 6 distinct product-problem codes appear in the reports, with False Positive Result topping the list at 456 reports. Reports are associated with 6 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 8 years of MAUDE data, with the peak single-year volume reaching 155 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 2 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.