Device product
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Z-1577-2023
Product summary
- 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
bug in this firmware