Z-0083-2022 Class II Ongoing
FDA device recall Z-0083-2022 was initiated by Roche Molecular Systems, Inc. on September 3, 2021 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 507 US; 6,676 ex- US.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- September 3, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 507 US; 6,676 ex- US
Product Description
Reason for Recall
Distribution Pattern
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.