BEUDAMED
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    The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1).

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LJY·August 8, 2005

    DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LOL·April 8, 2005

    DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LSE·November 1, 2004

    Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LFY·September 10, 2003

    DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LLM·March 14, 2007

    ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. manufactured for DiaSorin Inc., 1950 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LAZ·October 20, 2004

    ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LOM·August 19, 2010

    DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LKJ·March 1, 2010

    Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)

    FDA Recall
    Terminated ·Natus Medical Inc·Product code ETY·June 27, 2005

    MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.

    FDA Enforcement
    Class II ·Terminated·Nipro Diagnostics, Inc.·February 12, 2014

    Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

    FDA Enforcement
    Class II ·Terminated·Nipro Diagnostics, Inc.·April 24, 2013

    ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc·Product code GCJ·April 1, 2005

    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·November 23, 2016

    Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·June 14, 2017

    Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662

    FDA Recall
    Terminated ·Ebi, Llc·Product code LXH·August 13, 2013

    BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system

    FDA Recall
    Terminated ·Ebi, Llc·Product code HWC·August 22, 2013

    ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippany, NJ. 07054

    FDA Recall
    Terminated ·Ebi, Llc·Product code NKB·September 16, 2010

    Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

    FDA Recall
    Terminated ·Ebi, Llc·Product code HXX·September 29, 2012

    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.

    FDA Recall
    Terminated ·Ebi, Llc·Product code HXX·February 7, 2013

    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion

    FDA Recall
    Terminated ·Ebi, Llc·Product code HXX·September 24, 2013