Manufacturer
10 recalls in our database name Foundation Medicine, Inc. as the manufacturing or recalling firm.
Of the 10 recalls from Foundation Medicine, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Foundation Medicine is recalling 32 Hamilton Microlab STAR Liquid Handler units due to a software issue causing spontaneous closures.
Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx test, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants.
Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.
B. Braun Medical is recalling 23,160 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
Foundation Medicine is recalling 59 FoundationOne CDx reports that were sent to customers without the companion diagnostic Claims Page.
Foundation Medicine is recalling the FoundationOne Companion Diagnostic (F1CDx) due to an incorrect negative claim displayed on the claims page, though device variant information was correctly shown in the tumor profiling section of the approved test report.
Foundation Medicine is recalling two FoundationOne Companion Diagnostic (F1CDx) test reports that contained an incorrect negative claim on the claims page, though the device variant information displayed correctly in the tumor profiling section.
Foundation Medicine is recalling four FoundationOne Companion Diagnostic (F1CDx) test reports sent to customers that contained clinically relevant variants requiring amendment, including one with an incorrect negative companion diagnostic claim.
Foundation Medicine is recalling eight FoundationOne CDx test reports due to identified potential false positive MSI-H results.
Foundation Medicine is recalling 800 FoundationOne CDx test reports because an incorrect result for a single analyte may have been reported.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Foundation Medicine
American genomics company
Source: Wikidata (Q19604401), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.