Abbott Laboratories is recalling 833 Alinity hq Analyzers (Model 09P68-01) due to a software defect affecting versions 5.0 through 5.10.1. The issue prevents the system from properly applying warning flags to lab results when the device's sensors become saturated. This defect can lead to the reporting of incorrect diagnostic results without alerting the operator to the error. Abbott has initiated a voluntary correction to address the software problem.
The software failure means the analyzer may produce inaccurate medical test results without displaying the necessary warning indicators to laboratory staff. Incorrect results could lead to improper medical diagnoses or treatment decisions for patients.
Quantity affected: 833 units.
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Sources: FDA iRES · Raw API Response
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