Roche Molecular Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0083-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 3, 2021

Date Posted: October 20, 2021

Recall Number: Z-0083-2022

Event ID: 88607

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

Status: Ongoing

Product Quantity: 507 US; 6,676 ex- US

Code Information:

All lot numbers

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.

Voluntary or Mandated:

Voluntary: Firm initiated