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    DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LFX·December 16, 2009

    DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code MID·November 1, 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 Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285

    FDA Recall
    Terminated ·Diasorin Inc.·Product code MID·January 23, 2004

    Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code JJQ·December 5, 2008

    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code MLM·March 16, 2015

    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

    GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code CIB·October 12, 2009

    LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code CHP·July 13, 2016

    LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082

    FDA Recall
    Terminated ·Diasorin Inc.·Product code MRG·February 1, 2008

    Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LIP·March 16, 2005

    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

    DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.

    FDA Enforcement
    Class II ·Terminated·Diasorin Inc.·April 29, 2015

    LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON¿ Analyzer family.

    FDA Enforcement
    Class II ·Terminated·Diasorin Inc.·April 7, 2021

    LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.

    FDA Enforcement
    Class II ·Terminated·Diasorin Inc.·November 30, 2016

    PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DHN·June 30, 2004

    Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit

    FDA Recall
    Terminated ·Diasorin Inc.·Product code MLM·April 12, 2004

    DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples)

    FDA Recall
    Terminated ·Diasorin Inc.·Product code JNO·February 15, 2007

    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

    Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DBM·April 12, 2004