STA Compact Analyzer Firmware Bug Causes Inaccurate Test Results
Diagnostica Stago is recalling STA Compact Analyzers due to a firmware bug causing intermittent shortened coagulation times and increased technical errors. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a firmware defect affecting test result accuracy. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' resulting in a High severity score.
Plain-English summary
Diagnostica Stago, Inc. is recalling the STA Compact Automated Multi-Parametric Analyzer (Reference Numbers 58602 and 58612) due to a firmware bug identified during an internal investigation. The analyzers were distributed nationwide, with confirmed distribution in Illinois, Massachusetts, Minnesota, Nebraska, Texas, and Wisconsin.
The firmware bug can cause intermittent shortened coagulation times in test results and an increased frequency of technical error messages (error 13). These malfunctions may result in inaccurate patient test results that could affect clinical decisions.
Facilities using these analyzers should contact Diagnostica Stago, Inc. for instructions on applying a firmware update or other remedial actions. No illnesses or injuries have been reported.
The recalled product
- Product
- STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- firmware-bug
- test-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 036074505860
- Serial Numbers: 7096527 7116678
Distribution
Distributed nationwide across the United States.
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