Roche Molecular Systems, Inc. Recall 88607
Description: cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Roche Molecular Systems, Inc. Recall 88607 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0083-2022 |
| Event ID | 88607 |
| Event Description | cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190 |
| Product Type | Devices |
| 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. |
| Quantity | 507 US; 6,676 ex- US |
| Recall Reason | False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment |
| Device Classification | 20211020 |
| Device Code Info | All lot numbers |
| Center Classification Date | 20211008 |
| Recall Initiation Date | 20210903 |
| Recalling Firm | Roche Molecular Systems, Inc. |
| Initial Notification | Letter |
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