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    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDJ·April 28, 2014

    Continu-Flo Solution Set, 10 drops/mL, 104'', 0.22 Micron Downstream High Pressure Extended Life Filter, 3 Injection Sites, Male Luer Lock Adapter, catalog 2C6593; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code FPA·July 16, 2003

    Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra LifeSciences (Ireland) Limited, County Offaly, Ireland; Distributed by Integra Life Sciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code LFL·July 29, 2010

    Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ITX·October 9, 2008

    Clearlink System Vented Paclitaxel Set, 10 drops/mL, 111'', Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.22 Micron Extended Life Filter, Luer Activated Valve, Male Luer Lock Adapter, catalog 2C8857; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code FPA·July 16, 2003

    Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where x-ray imaging modalities will be used.

    FDA Recall
    Terminated ·Integra LifeSciences Corporation·Product code FWZ·May 19, 2010

    Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16'', 4.2 mL Vol., with 0.22 Micron Downstream High Pressure Extended Life Filter, 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·July 6, 2005

    CTSTM Essential 8 Medium

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code N/A·June 11, 2019

    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 therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·December 4, 2017

    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code QJR·August 6, 2020

    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code NYQ·May 13, 2013

    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·February 8, 2018

    The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code QJR·August 6, 2020

    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.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

    FDA Recall
    Open, Classified ·Life Technologies Corporation·Product code PFF·February 7, 2024

    StemPro MSC SFM CTS"

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code NDS·June 11, 2019

    SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Invitrogen Corporation 7335 Executive Way Frederick MD 21704 www.invitrogen.com*** Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code NYQ·November 14, 2011

    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

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    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

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    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

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020