System, Identification, Hepatitis B Antigen

What the Data Shows About System, Identification, Hepatitis B Antigen

The FDA MAUDE database aggregates 472 adverse-event reports for System, Identification, Hepatitis B Antigen spanning the period from 1997 through 2020. Of these, 0 are classified as death reports, 17 as injury reports, and 453 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 3 distinct event types and 4 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 9 distinct product-problem codes appear in the reports, with False Positive Result topping the list at 129 reports. Reports are associated with 9 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 79 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 3 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.