Every recall we track for Foundation Medicine, Inc. — 10 in all — plus the complaints and injury reports the public filed about them.
Foundation Medicine recalls Hamilton Microlab STAR Liquid Handler Protocol Configuration Tool v2.0.0 due to software issues causing spontaneous closures. Affected units include specific equipment IDs for F1CDx and F1LCDx testing.
Foundation Medicine recalls PCT software v1.3.0 for Hamilton AutoLys STAR used in FoundationOneCDx. Potential for spontaneous software closures during autolys protocols after deployment.
Foundation Medicine recalls Sequencing Agent SEQ0067 (lot 24346, 24386, 24488) due to possible false-positive BARD1 variants in cancer testing. Affected users should contact for details.
Foundation Medicine recalls F1CDx companion diagnostic due to four reports of clinically relevant variants requiring amendment, one with incorrect negative claim. No remedy specified in recall notice.
Foundation Medicine recalls F1CDx companion diagnostic reports with incorrect negative claims. Affected reports may have inaccurate results; contact for remedy.
Foundation Medicine recalls FoundationOne Companion Diagnostic (F1CDx) due to incorrect negative claim on claims page. This may affect test accuracy but does not pose immediate safety risks.
Foundation Medicine recalls F1LCDx version 6.0 due to missing companion diagnostic claims page. Affected units may not have the required claims page, potentially impacting test results. Contact for remedy details.
Foundation Medicine recalls F1CDx version 31.0 due to missing companion diagnostic claims page. Affected units may not function properly without the required claims page.
Foundation Medicine recalls specific FoundationOne CDx test reports that may show false positive MSI-H results, which could lead to incorrect cancer treatment decisions.
Foundation Medicine recalls FoundationOne CDx Test Results for up to 800 physician reports that may have shown incorrect results for a single analyte. Affected reports can be identified by specific specimen numbers.
