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Recall Observatory FDA recall evidence

Device product

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

Z-1577-2023

March 22, 2023

Class II

Product summary

Firm
Diagnostica Stago, Inc.
Event
Event 92007
Status
Ongoing
Classification
Class II
Quantity
5 analyzers
Official record key
device-enforcement:Z-1577-2023

Official wording

Reason: 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).

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

Distribution pattern: US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    bug in this firmware