Diagnostica Stago, Inc.: STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612

Hazard

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

Details from the source

Reason for recall: An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13). Distribution: US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI. Quantity: 2 analyers Lot/code info: UDI-DI: 036074505860; Serial Numbers: 7096527 7116678

UPC codes

036074505860

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.