FoundationOne CDx test report recall
FoundationOne CDx test report
Why was FoundationOne CDx test report recalled?
Identified potential false positive MSI-H on the test reports provided to the physicians.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Lot/Serial Number: QRF150009.01 , QRF150228.01 , QRF150108.01 , QRF149795.01, QRF150117.01 , QRF150247.01 , QRF149634.01 , QRF128938.01
- Product
- FoundationOne CDx test report
- Recalling firm
- Foundation Medicine, Inc.
- Quantity
- 8 reports
- Distribution
- MA, NC,IN, OH, GA
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)