Foundation Medicine, Inc. recalls FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Read the official notice →- Date
- 2025-12-03
- Country
- United States
- Brand
- Foundation Medicine
- Product
- FoundationOne CDx (F1CDx), RAL-0003 version 31.0
- Classification
- Class II
- Units
- US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Foundation Medicine recalls
- 2026-08-26
USFoundation Medicine, Inc. recalls Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Software issue that can cause an increase in spontaneous software closures.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution in the states of MA & NC.Official notice →- 2026-04-29
- US
Foundation Medicine, Inc. recalls Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research…
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
FDA · DeviceFoundation Medicine, Inc.US distribution to North Carolina and Massachusetts.Official notice → - US
Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution in the states of Massachusetts and North Carolina.Official notice → - 2025-06-11
- US
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution in the state of WI.Official notice → - US
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution in the state of MI.Official notice → - 2025-05-21
- US
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes…
FDA · DeviceFoundation Medicine, Inc.Worldwide - US Nationwide distribution in the states of GA, NY and the country…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-03
- US
Alcon Research LLC recalls CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+…
XXX
FDA · DeviceAlcon Research LLCWorldwide - US Nationwide distribution including in the states of PA, MN, CA,…Official notice → - US
Medtronic Sofamor Danek USA Inc recalls Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT…
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be…
FDA · DeviceMedtronic Sofamor Danek USA IncWorldwide distribution - US Nationwide and Puerto Rico. The countries of…Official notice → - US
Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product…
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these…
- US
Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
- US
Glycar SA Pty., Ltd. recalls SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
The impacted lot may not meet the required tensile strength specification.
- US