FDA-Device2023-05-17Class II
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Diagnostica Stago, Inc.
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).
Sold states
US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
Affected count
2 analyers
Manufactured in
5 Century Dr, N/A, Parsippany, NJ, United States
Products
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1576-2023Don't want to check this manually?
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