Diagnostica Stago, Inc.: 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).

Agency Publication Date: May 10, 2023

Affected Products

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

UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744

Product: STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612

UDI-DI: 036074505860; Serial Numbers: 7096527 7116678

Product: STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

UDI-DI: 036074505898; Serial Numbers: 5061471 5061474 0000007405 CF70015885 CF70015886

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92007

Status: Active

Manufacturer: Diagnostica Stago, Inc.

Manufactured In: United States

Units Affected: 3 products (6 analyzers; 2 analyers; 5 analyzers)

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Sources: FDA iRES · Raw API Response

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