Reported Dec 26, 2018 · Terminated
FoundationOne CDx Test Results
Foundation Medicine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Foundation Medicine, Inc. · 150 2nd St · Cambridge, MA · 02141-2115
Is this the product you have?
- FoundationOne CDx Test Results
- Lot codes and dates
- Specimen Numbers -
832 of 832 codes
QRF038638QRF039891QRF041785QRF045568QRF045791QRF046784QRF046978QRF047089QRF048328QRF048779QRF049054QRF049231QRF049653QRF049780QRF049795QRF050115QRF050274QRF050299QRF050506QRF051201QRF051302QRF051412QRF051560QRF051610QRF051635QRF051756QRF051768QRF051787QRF051832QRF051882QRF051892QRF051920QRF051925QRF051943QRF051952QRF051954QRF051968QRF051975QRF051979QRF051982QRF051987QRF052308QRF052311QRF052315QRF052324QRF052327QRF052356QRF052356QRF052363QRF052364QRF052387QRF052391QRF052392QRF052395QRF052423QRF052425QRF052438QRF052448QRF052467QRF052486
- Specimen Numbers -
- Amount recalled
- 800 reports
Where it was sold
- Nationwide
Why it was recalled
An incorrect test result for a single analyte may have been reported for up to 800 physician reports
This product could cause temporary or reversible health problems — stop using it.
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