Foundation Medicine is recalling 10 units of the Protocol Configuration Tool (PCT) software v1.3.0 used with Hamilton AutoLys STAR laboratory equipment. The software, used within FoundationOneCDx (F1CDx) testing protocols, can spontaneously close while running. This defect was identified at the Research Triangle Park laboratory; no incidents or injuries have been reported to date. Foundation Medicine initiated this voluntary recall via email to notify the affected laboratory sites.
The software can unexpectedly shut down during active laboratory protocols, which could interrupt critical diagnostic testing and potentially lead to delays in patient results or the need for re-testing.
Software used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory equipment.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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