Exact FDA event identifier

Event 83729

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: August 08, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Foundation Medicine, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

FoundationOne CDx test report

Z-0535-2020

Recall number: Z-0535-2020
Initiated: August 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Foundation Medicine, Inc.
Quantity: 8 reports

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Identified potential false positive MSI-H on the test reports provided to the physicians.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Identified potential false positive MSI-H on the test reports provided to the physicians.

Code information

Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01

Distribution pattern

MA, NC,IN, OH, GA