MAUDE adverse event: Beckman Coulter, Inc - ACCESS 2 IMMUNOASSAY ANALYZER

Reported to the FDA Sep 22, 2026 (event Dec 6, 2024). The FDA publishes these reports weeks after receipt. The customer reported receiving unexpectedly high Access hsTnI (Part Number B52699) patient results on an Access 2 Analyzer (serial number (b)(6)). No adverse patient impact, injur