cobas EGFR Mutation Test v2-Somatic gene mutation recall
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Why was cobas EGFR Mutation Test v2-Somatic gene mutation recalled?
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
All lot numbers
- Product
- cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 507 US; 6,676 ex- US
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, UK, Poland, Spain, Italy, Sweden, Greece, Denmark, Norway, Netherlands, France, Czech Republic, Belgium, Austria, Slovakia, Hungary, Switzerland, Lithuania, Slovenia. Serbia, North Macedonia, Myanmar, Lebanon, Russia, Croatia, Morocco, Kazakhstan, Dominican Republic, Israel, El Salvador, Vietnam, Malaysia, Taiwan, China, Japan, Hong Kong, Korea, Brazil, Philippines, Thailand, Chile, Colombia, Singapore, Argentina, Australia, India, Uruguay, Ecuador, Panama, Costa Rica, Pakistan, Peru, Indonesia, New Zealand.
- Recall date
- October 20, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)