FoundationOne CDx Test Results
Medical device recall Z-0649-2019. Published in FDA’s Enforcement Report on Dec 26, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 26, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 800 reports how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
FoundationOne CDx Test Results
800 reports, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Specimen Numbers - QRF038638 QRF039891 QRF041785 QRF045568 QRF045791 QRF046784 QRF046978 QRF047089 QRF048328 QRF048779 QRF049054 QRF049231 QRF049653 QRF049780 QRF049795 QRF050115 QRF050274 QRF050299 QRF050506 QRF051201 QRF051302 QRF051412…
Every code shown here, 1,999 characters
Specimen Numbers - QRF038638 QRF039891 QRF041785 QRF045568 QRF045791 QRF046784 QRF046978 QRF047089 QRF048328 QRF048779 QRF049054 QRF049231 QRF049653 QRF049780 QRF049795 QRF050115 QRF050274 QRF050299 QRF050506 QRF051201 QRF051302 QRF051412 QRF051560 QRF051610 QRF051635 QRF051756 QRF051768 QRF051787 QRF051832 QRF051882 QRF051892 QRF051920 QRF051925 QRF051943 QRF051952 QRF051954 QRF051968 QRF051975 QRF051979 QRF051982 QRF051987 QRF052308 QRF052311 QRF052315 QRF052324 QRF052327 QRF052356 QRF052356 QRF052363 QRF052364 QRF052387 QRF052391 QRF052392 QRF052395 QRF052423 QRF052425 QRF052438 QRF052448 QRF052467 QRF052486 QRF052507 QRF052509 QRF052509 QRF052518 QRF052521 QRF052539 QRF052580 QRF052581 QRF052587 QRF052886 QRF052905 QRF053180 QRF053280 QRF053574 QRF053624 QRF053630 QRF053637 QRF053651 QRF053808 QRF054060 QRF054282 QRF054282 QRF054297 QRF054300 QRF054309 QRF054335 QRF054358 QRF054390 QRF054393 QRF054400 QRF054439 QRF054446 QRF054446 QRF054478 QRF054490 QRF054500 QRF054501 QRF054533 QRF054540 QRF054549 QRF054565 QRF054570 QRF054571 QRF054600 QRF054602 QRF054611 QRF054615 QRF054617 QRF054620 QRF054621 QRF054622 QRF054623 QRF054628 QRF054631 QRF054633 QRF054636 QRF054640 QRF054642 QRF054645 QRF054646 QRF054648 QRF054649 QRF054651 QRF054653 QRF054657 QRF054659 QRF054660 QRF054664 QRF054665 QRF054666 QRF054687 QRF054689 QRF054690 QRF054691 QRF054694 QRF054695 QRF054697 QRF054698 QRF054700 QRF054701 QRF054702 QRF054703 QRF054704 QRF054705 QRF054706 QRF054708 QRF054710 QRF054712 QRF054714 QRF054715 QRF054716 QRF054717 QRF054719 QRF054721 QRF054724 QRF054725 QRF054728 QRF054729 QRF054732 QRF054733 QRF054734 QRF054736 QRF054737 QRF054738 QRF054739 QRF054740 QRF054742 QRF054743 QRF054746 QRF054748 QRF054750 QRF054751 QRF054752 QRF054753 QRF054754 QRF054755 QRF054756 QRF054756 QRF054757 QRF054759 QRF054760 QRF054760 QRF054762 QRF054763 QRF054764 QRF054765 QRF054766 QRF054768 QRF054770 QRF054771 QRF054775 QRF054776 QRF054779 QRF054780 QRF054781 QRF054782 QRF054783 QRF054784…
FDA’s list runs to 8,338 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 31, 2018.
- FDA classified it on Dec 20, 2018.
- FDA’s Enforcement Report published it on Dec 26, 2018.
- FDA terminated it on Apr 17, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Foundation Medicine, Inc., of Cambridge, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 8,338 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.