Recall Z-0083-2022— Roche Molecular Systems, Inc.

Name: FDA recall Z-0083-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-03

Class II · Ongoing

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2021-09-03. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190. 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.

Recalling firm: Roche Molecular Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-03
Firm location: Branchburg, NJ, United States

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.