# FDA recall Z-0083-2022

> **Roche Molecular Systems, Inc.** · Class II · device recall initiated 2021-09-03.

## Product

cobas EGFR Mutation Test v2-Somatic gene mutation detection system  Catalog Number :07248563190

## 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.

## Key facts

- **Recall number:** Z-0083-2022
- **Recalling firm:** Roche Molecular Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-03
- **Report date:** 2021-10-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Branchburg, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2022

## Citation

> AI Analytics. FDA recall Z-0083-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0083-2022. Source: US FDA. Licensed CC0.

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