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.
Read the official notice →- Date
- 2026-04-29
- Country
- United States
- Brand
- Foundation Medicine
- Product
- Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research…
- Classification
- Class II
- Units
- US distribution to North Carolina and Massachusetts.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 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 → - 2025-12-03
- US
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.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY,…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
- 2026-05-06
- US
- US
Alcon Research LLC recalls GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC:…
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- 2026-04-29
- US
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
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LSL Healthcare Inc. recalls LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
FDA · DeviceLSL Healthcare Inc.US Nationwide distribution in the states of MD, IL, MN.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 → - US
SurgiSmoke Solutions recalls Flamingo Funnel Small, Model Number SQ20012-01
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
FDA · DeviceSurgiSmoke SolutionsWorldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD,…Official notice →