STA Compact Max analyzer firmware bug causes inaccurate test results
A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.
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: The FDA classified this recall as Class II. The firmware defect directly affects clinical test result accuracy without any reported illnesses or injuries to date. Inaccurate coagulation times represent a risk-of-harm to patients if undetected.
Plain-English summary
The FDA is recalling the STA Compact Max fully automatic clinical analyzer (Reference Numbers 58602 and 58612) manufactured by Diagnostica Stago, Inc. This medical device is used in clinical laboratories for automated blood coagulation testing.
A firmware bug in affected units causes intermittent shortened coagulation times and an increased frequency of technical error messages (error 13). These malfunctions result in inaccurate test results.
Five analyzers with this defect were distributed nationwide in Illinois, Massachusetts, Minnesota, Nebraska, Texas, and Wisconsin. The device serial numbers affected are: 5061471, 5061474, 0000007405, CF70015885, and CF70015886.
The recalled product
- Product
- STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- firmware-bug
- inaccurate-results
- device-malfunction
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: 036074505898
- Serial Numbers: 5061471 5061474 0000007405 CF70015885 CF70015886
Distribution
Distributed nationwide across the United States.
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