STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
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).
US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1575-2023