cobas¿ EGFR Mutation Test epidermal growth factor recall
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Why was cobas¿ EGFR Mutation Test epidermal growth factor recalled?
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
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?
T08661
- Product
- cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 190 kits
- Distribution
- Foreign
- Recall date
- April 1, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)