Recall Z-2254-2016— Roche Molecular Systems, Inc.

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2016-04-05, terminated 2017-12-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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).. Reason: 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..

Recalling firm

Roche Molecular Systems, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-04-05

Terminated

2017-12-11

Firm location

Branchburg, NJ, United States

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