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    BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code DHC·July 14, 2009

    Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

    FDA Recall
    Terminated ·Integra Limited·Product code GWM·September 10, 2013

    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-A-HC-PERC8, G12566.

    FDA Recall
    Terminated ·Cook, Inc.·Product code JOH·April 21, 2010

    Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.

    FDA Recall
    Terminated ·Cook, Inc.·Product code JOH·April 21, 2010

    Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs

    FDA Recall
    Terminated ·Cook Inc.·Product code FOZ·July 31, 2017

    Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

    FDA Recall
    Terminated ·DPC Cirrus·Product code DHA·October 29, 2004

    Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.

    FDA Recall
    Terminated ·DPC Cirrus·Product code JJE·June 13, 2003

    IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836

    FDA Recall
    Terminated ·DPC Cirrus·Product code JJE·April 22, 2005

    A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.

    FDA Recall
    Terminated ·A-Dec Inc·Product code KLC·April 1, 2009

    Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DFC·May 16, 2018

    K-Assay Lp(a) Control

    FDA Recall
    Terminated ·Kamiya Biomedical Company·Product code DFC·March 29, 2004

    Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System .

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DFC·January 10, 2005

    Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237*** Product Usage: The Lp(a) calibrator is intended to be used with the Wako Autokit Lp(a) test to establish the points of reference that are used in the determination of Lp(a) in serum or plasma.

    FDA Recall
    Terminated ·Wako Chemicals USA, Inc.·Product code DFC·January 30, 2012

    Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DDC·October 26, 2006

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018

    DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018

    DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018

    CombiDiagnost R90 (Stitching Patient Support) 709030

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018

    EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018

    DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018