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    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
    Terminated ·Roche Molecular Systems, Inc.·Product code OWD·April 5, 2016

    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OWD·December 11, 2020

    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.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OWD·December 18, 2014

    cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OWD·January 13, 2015

    cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OWD·March 15, 2016

    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OWD·July 31, 2012

    VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X200MM STR STD BODY/NECK REV 13.5X200MM BWD RT REV 15.0X200MM BWD LT REV 15.0X200MM BWD RT REV 16.5X200MM BWD LT REV 16.5X200MM BWD RT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LPH·November 29, 2017

    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code NDP·March 11, 2013

    UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·January 31, 2020

    Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Segmental fluted stem, 18x250mm bwd, Sterile,

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer*** This release of the iE33 Ultrasound System supports the S8-3t transesophageal echocardiographic (TEE) transducer***Manufactured by Philips Ultrasound***22100 Bothell-Everett Highway***Bothell, WA 98021-8431***USA***Telephone: +1 425-487-7000 or 800-426-2670***Fax: +1 425-485-6080***www.philips.com/ultrasound***". The S8-3t transducer is indicated for adult cardiac, pediatric cardiac and transesophageal uses, and operates in the following modes: B, M, Color M, CWD, PWD, high PRF, color Doppler, harmonic, XRES. The S8-3t Micro TEE is indicated for use on patients weighing at least 2.5 kg undergoing echocardiography exams in the ICU, echocardiography lab, interventional suite, or in the operating room during cardiac surgery. The S8-3t Micro TEE transducer can be identified by the designation "S8-3t" printed on the connector housing of the transducer.

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code IYN·March 27, 2011

    Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017

    R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code MRA·March 11, 2011

    R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code MRA·March 11, 2011

    R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code MRA·March 11, 2011

    R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code MRA·March 11, 2011