Diagnostica Stago, Inc.: STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026

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: 6 analyzers Lot/code info: UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744

UPC codes

036074505901

Source

Official record: FDA (Device enforcement) ↗

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