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Terminated

cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).

FDA Recall Z-2254-2016 · Posted None

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeOWD
Date Initiated2016-04-05
Date Terminated2017-12-11
Product Quantity735 devices EGFR; 509 devices cfDNA

Reason for Recall

During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.

Firm Action

Roche Molecular Diagnostics sent an Urgent Field Safety Notice letter dated April 5, 2016 to affected customers. Then letter identified the affected product, problem and actions to be taken. The Instructions for use are provided for the user until new ones are available..

Root Cause

Nonconforming Material/Component

Distribution Pattern

Foriegn Distribution Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom cfDNA: Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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