Home / Recalls / Roche Molecular Systems, Inc. / Z-2254-2016

Z-2254-2016 Class II Terminated

Recalled by Roche Molecular Systems, Inc. — Branchburg, NJ

FDA device recall Z-2254-2016 was initiated by Roche Molecular Systems, Inc. on April 5, 2016 and is designated Class II. 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… The recall status is terminated (terminated December 11, 2017). Affected quantity: 735 devices EGFR; 509 devices cfDNA.

Recall Details

Product Type: Devices
Report Date: July 27, 2016
Initiation Date: April 5, 2016
Termination Date: December 11, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 735 devices EGFR; 509 devices cfDNA

Product Description

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 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.

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

Code Information

Lot W08792, Lot W11783, Lot W11438, Lot W14903, Lot W05108. Lot W11435, Lot W12238

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