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Lower risk Medical device recall · FDA · Published November 8, 2022

FoundationOne CDx (F1CDx) RAL-0003 v31.0: Missing Claims Page Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0577-2026Medical deviceFoundation Medicine ›
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Recalling firmFoundation Medicine, Inc.150 2nd St · Cambridge, MA 02141-2115
✎ GovInfoNow plain-language explainer

Foundation Medicine is recalling F1CDx version 31.0 because some units were sent without the companion diagnostic claims page. This could prevent proper use of the test without the required claims page. Read more at govinfonow.com/recall/59483-foundationone-cdx-f1cdx-ral-0003-v31-0-missing-claims-page.

Source Summary by GovInfoNow · govinfonow.com/recall/59483-foundationone-cdx-f1cdx-ral-0003-v31-0-missing-claims-page · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0577-2026

Cite this page

“FoundationOne CDx (F1CDx) RAL-0003 v31.0: Missing Claims Page Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59483-foundationone-cdx-f1cdx-ral-0003-v31-0-missing-claims-page. Based on FDA recall #Z-0577-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0577-2026%22&limit=1).

The FDA announced on Nov. 8, 2022, that Foundation Medicine, Inc. is recalling its FoundationOne CDx (F1CDx), RAL-0003 version 31.0 device because reports were sent to customers without the companion diagnostic Claims Page. The agency classified the recall as Class II and ongoing.

How to tell if you have it

  • Foundation Medicine
  • FoundationOne CDx (F1CDx)
  • RAL-0003 version 31.0
  • Test Numbers: ORD-XXXX425-01 (JP), ORD-XXX5703-01 (JP), ORD-XXXX467-01 (JP), ORD-XXXX474-01 (JP), ORD-XXXX460-01 (JP), ORD-XXXX612-01 (JP), ORD-XXXX484-01 (JP), ORD-XXXX440-01 (JP), ORD-XXXX665-01 (JP), ORD-XXXX699-01 (JP), ORD-XXXX546-01 (JP), ORD-XXXX689-01 (JP), ORD-XXXX695-01 (JP), ORD-XXXX451-01 (JP), ORD-XXXX455-01 (JP), ORD-XXXX476-01 (JP), ORD-XXXX481-01 (JP), ORD-XXXX477-01 (JP), ORD-XXXX509-01 (SG), ORD-XXXX511-01 (SG), ORD-XXXX985-01 (US), ORD-XXXX071-01 (US), ORD-XXXX731-01 (US), ORD-XXXX999-01 (US), ORD-XXXX069-01 (US), ORD-XXXX352-01 (US), ORD-XXXX993-01 (US), ORD-XXXX294-01 (US), ORD-XXXX822-01 (US), ORD-XXXX210-01 (US), ORD-XXXX683-01 (US), ORD-XXXX979-01 (US), ORD-XXXX413-01 (US), ORD-XXXX843-01 (US), ORD-XXXX316-01 (US), ORD-XXXX960-01 (US), ORD-XXXX001-01 (US), ORD-XXXX804-01 (US), ORD-XXXX600-01 (US), ORD-XXXX940-01 (US), ORD-XXXX367-01 (US), ORD-XXXX771-01 (US), ORD-XXXX169-01 (US), ORD-XXXX296-01 (US), ORD-XXXX290-01 (US), ORD-XXXX320-01 (US), ORD-XXXX255-01 (US), ORD-XXXX897-01 (US), ORD-XXXX377-01 (US), ORD-XXXX252-01 (US), ORD-XXXX475-01 (US), ORD-XXXX545-01 (US), ORD-XXXX690-01 (US), ORD-XXXX378-01 (US), ORD-XXXX740-01 (US), ORD-XXX1300-01 (US), ORD-XXXX470-01 (US), ORD-XXXX424-01 (US), ORD-XXXX115-01 (US)

The hazard

According to the FDA, the hazard involves reports being sent to customers without the companion diagnostic Claims Page. The agency noted that claims pages were distributed via amended reports within 7 days of the issue occurrence.

Context

GovInfoNow's records show Foundation Medicine, Inc. has had 8 other recalls on record since Oct. 31, 2018. Other recent recalls include the Hamilton Microlab STAR Liquid Handler PCT v2.0.0 Software Recall (June 10, 2026) and the AutoLys STAR PCT software v1.3.0 recall (March 24, 2026), both involving spontaneous software closures. A March 20, 2026 recall of the Sequencing Agent SEQ0067 addressed potential false-positive BARD1 artifacts.

How to tell if you have this one

Check for the product name 'FoundationOne CDx (F1CDx)' with version number RAL-0003 v31.0. The test was distributed with specific order numbers in the US, Singapore, and Japan.

  • Brand
    Foundation Medicine
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.
Recall numberProduct, codes & lotsQuantity
Z-0577-2026FoundationOne CDx (F1CDx), RAL-0003 version 31.0; F1CDX - RAL-0003 version 31.0; Test Numbers: ORD-XXXX425-01 (JP), ORD-XXX5703-01 (JP), ORD-XXXX467-01 (JP), ORD-XXXX474-01 (JP), ORD-XXXX460-01 (JP), ORD-XXXX612-01 (JP), ORD-XXXX484-01 (JP), ORD-XXXX440-01 (JP), ORD-XXXX665-01 (JP), ORD-XXXX699-01 (JP), ORD-XXXX546-01 (JP), ORD-XXXX689-01 (JP), ORD-XXXX695-01 (JP), ORD-XXXX451-01 (JP), ORD-XXXX455-01 (JP), ORD-XXXX476-01 (JP), ORD-XXXX481-01 (JP), ORD-XXXX477-01 (JP), ORD-XXXX509-01 (SG), ORD-XXXX511-01 (SG), ORD-XXXX985-01 (US), ORD-XXXX071-01 (US), ORD-XXXX731-01 (US), ORD-XXXX999-01 (US), ORD-XXXX069-01 (US), ORD-XXXX352-01 (US), ORD-XXXX993-01 (US), ORD-XXXX294-01 (US), ORD-XXXX822-01 (US), ORD-XXXX210-01 (US), ORD-XXXX683-01 (US), ORD-XXXX979-01 (US), ORD-XXXX413-01 (US), ORD-XXXX843-01 (US), ORD-XXXX316-01 (US), ORD-XXXX960-01 (US), ORD-XXXX001-01 (US), ORD-XXXX804-01 (US), ORD-XXXX600-01 (US), ORD-XXXX940-01 (US), ORD-XXXX367-01 (US), ORD-XXXX771-01 (US), ORD-XXXX169-01 (US), ORD-XXXX296-01 (US), ORD-XXXX290-01 (US), ORD-XXXX320-01 (US), ORD-XXXX255-01 (US), ORD-XXXX897-01 (US), ORD-XXXX377-01 (US), ORD-XXXX252-01 (US), ORD-XXXX475-01 (US), ORD-XXXX545-01 (US), ORD-XXXX690-01 (US), ORD-XXXX378-01 (US), ORD-XXXX740-01 (US), ORD-XXX1300-01 (US), ORD-XXXX470-01 (US), ORD-XXXX424-01 (US), ORD-XXXX115-01 (US),59 units (39 US, 20 OUS)
Z-0578-2026FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0; F1LCDx - TECH-0009 version 6.0; Test Numbers: ORD-XXX6703-01 (JP), ORD-XXXX411-01 (US), ORD-XXXX128-01 (US), ORD-XXXX061-01 (US), ORD-XXXX270-01 (US), ORD-XXXXX94-01 (US), ORD-XXXX058-01 (US), ORD-XXXX099-01 (US), ORD-XXXX089-01 (US), ORD-XXXX252-01 (US), ORD-XXXX640-01 (US), ORD-XXX5300-01 (US), ORD-XXXX453-01 (US), ORD-XXXX101-01 (US), ORD-XXXX070-01 (US), ORD-XXXX231-01 (US), ORD-XXXX496-01 (US), ORD-XXXX202-01 (US),18 units (17 US, 1 OUS)
Based on the official FDA remedy

What to do — step by step

  1. Check for Claims Page

    Ensure you have the companion diagnostic claims page included with your test kit.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 28 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY, ME, MN, MO, MS, MT, NC, NJ, NV, NY, OK, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV. OUS International to countries: Japan, Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3.1 years after the firm started it.

1. Firm started the recall: Nov 8, 202212. FDA classified it Class II: Nov 21, 202523. Published in FDA’s Enforcement Report: Dec 3, 2025320222025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0577-2026 (November 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0577-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA