CLASS II ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report
FoundationOne Companion Diagnostic (F1CDx) recalled
Foundation Medicine is recalling FoundationOne Companion Diagnostic (F1CDx), distributed nationwide in the US. The recall was initiated on 9 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1747-2025
- FDA event ID
- 96621
- Recalling firm
- Foundation Medicine, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Apr 2025
- FDA classified
- 12 May 2025
- Reported
- 21 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Apr 2025 | Recall initiated by company | |
| 12 May 2025 | Classified by FDA | +33 days |
| 21 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 did not impact CDx indications.
Product as listed by the FDA
FoundationOne Companion Diagnostic (F1CDx)
Where it was distributed
Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
Questions about this recall
Why was it recalled?
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 did not impact CDx indications.
Which lots are affected?
ORD-XXXXX28-01 ORD-XXXXX98-01 ORD-XXXXX29-01 ORD-XXXXX99-01 Note: The above characters have been redacted to minimize patient information disclosure.
Where was it sold?
Worldwide - US Nationwide distribution in the states of GA, NY and the country of Russia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Foundation Medicine
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hamilton Microlab STAR Liquid Handler recalled by Foundation Medicine | Foundation Medicine | Device Malfunction | Nationwide |
| Device | CLASS II | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) recalled | Foundation Medicine | Other | Nationwide |
| Device | CLASS II | Protocol Configuration Tool (PCT) recalled by Foundation Medicine | Foundation Medicine | Device Malfunction | MA, NC |
| Device | CLASS II | FoundationOne Liquid CDx (F1LCDx), Tech recalled by Foundation Medicine | Foundation Medicine | Other | Nationwide |
| Device | CLASS II | FoundationOne CDx (F1CDx), RAL recalled by Foundation Medicine | Foundation Medicine | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |