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    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 22, 2024

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·May 22, 2024

    ACL TOP 700 LAS, automated coagulation laboratory instrument.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·June 3, 2014

    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.

    FDA Recall
    Terminated ·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011

    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code JBD·June 29, 2004

    RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code GKA·September 14, 2004

    Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code JIA·September 8, 2004

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·December 5, 2018

    UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·December 5, 2018

    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code LPC·June 1, 2022

    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code LPC·October 14, 2022

    Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Manufactured by Suinsa C Primavera, 39 Pol. Ind. Las Monjas, Tarrejon de Ardaz Madrid 28850 Spain

    FDA Recall
    Terminated ·GE Healthcare·Product code KXJ·August 1, 2007

    Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code N/A·August 19, 2014

    Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code LAS·October 3, 2013

    Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code JZG·March 9, 2018

    ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 7, 2015

    Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·August 3, 2012

    ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·August 13, 2010

    ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JQP·December 16, 2014

    ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code GKP·July 19, 2013