Diagnostica Stago, Inc.: STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

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: 5 analyzers Lot/code info: UDI-DI: 036074505898; Serial Numbers: 5061471 5061474 0000007405 CF70015885 CF70015886

UPC codes

036074505898

Source

Official record: FDA (Device enforcement) ↗

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