cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Summary
The FDA issued a Class II for cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Numb by Roche Molecular Systems, Inc.. Reason: False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate tre.
Details
Source
Device Recall
External ID
Z-0083-2022
Action Date
2021-10-20
Status
Ongoing
Category
device
Product Description
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Lot/Code Info: All lot numbers
Quantity Affected: 507 US; 6,676 ex- US
Reason for Recall
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-03
Company
Branchburg, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Roche Molecular Systems, Inc. has 27 FDA actions in our database, including 7 recalls and 20 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Roche Molecular Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Roche Molecular Systems, Inc. have FDA actions?
Roche Molecular Systems, Inc. has 27 FDA actions in our database, including 7 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0083-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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