Life Technologies Corporation - Oncomine Target Dx Test - Class 2 Recall
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - Oncomine Target Dx Test - Class 2 Recall
Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - Ion Torrent Dx No Template Control Kit - Class 2 Recall
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - Oncomine Target Dx Test - Class 2 Recall
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - Oncomine Dx Target Test - Class 2 Recall
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted thera...
Source: Medical Device Recalls - March 31, 2018 Category: Medical Devices Source Type: alerts
Roche Molecular Systems, Inc. - Roche Molecular Diagnostics Inc. - Class 2 Recall
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). (Source:...
Source: Medical Device Recalls - July 22, 2016 Category: Medical Equipment Source Type: alerts
Roche Molecular Systems, Inc. - Roche Molecular Diagnostics - Class 3 Recall
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
