BEUDAMED
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    IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code CGN·November 6, 2013

    Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 22, 2019

    ADVIA Centaur Folate (FOL)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 2, 2018

    Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 22, 2019

    IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx Folate Mode 1 Calibrator 3.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003

    AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on the AxSYM System; list 3C81-20

    FDA Recall
    Terminated ·Abbott Laboratories·Product code CGN·January 19, 2009

    Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGN·July 24, 2012

    Access and Access 2 Immunoassay System

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code CGN·April 3, 2008

    AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code CGN·April 23, 2007

    ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013

    IMMULITE 2000/IMMULITE 2000 XPi Folic Acid

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 2, 2018

    ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013

    Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·November 14, 2012

    AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CGN·November 30, 2018

    AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003

    ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003

    ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013

    Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGN·September 15, 2006

    ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013

    IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 60064 USA

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003