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Diagnostica Stago, Inc. recalls STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Recalled May 17, 2023 · FDA recall Z-1576-2023 · Diagnostica Stago
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). · FDA Class II
Units
2 analyers
Sold at
US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
Description
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).
Product
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Manufacturer(s)
Diagnostica Stago, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →