Foundation Medicine, Inc. recalls FoundationOne CDx test report
Recalled Product
FoundationOne CDx test report
Hazard / Issue
Identified potential false positive MSI-H on the test reports provided to the physicians.
Issued by
FDA
Affected States: MA, NC, IN, OH, GA
Lot/Code Info: Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
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