Device Recall DiaSorin

Catalog Number 31 0680, 31 0680-CN

Clinical Chemistry and Clinical Toxicology Devices

1

No

USA (nationwide) Distribution and Worldwide Distribution including the states of : AR, AZ, CA, FL, ID, NJ, NV, NY and PA.., and to the countries of : Saudi Arabia, Colombia, Mauritius, Iraq, Mongolia, Greece, Albania, Austria, Bosnia, Bosnia Herzegovina, Belarus, Bulgaria, Macedonia, Poland, Serbia, Dominican Rep., Tunisia, Paraguay, Hungary, Jordan, Egypt, Belgium, Caribbean, Germany, Brazil, Mexico, Italy, India, South Korea, Cyprus, Bangladesh, Morocco, Chile, Bahrain, Palestine, Utd.Arab.Emir., Kosovo, Uruguay, Venezuela, Hungary, Australia, Vietnam, Sri Lanka, Turkey, Vietnam, Romania, Mauritius, Ecuador, Lebanon, Nepal, Argentina, Hong Kong, China and Canada.

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.

catalog # 7800, lot # 039229, expiration date 12/23/04

Immunology and Microbiology Devices

2

No

GA, NY & KS

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

version 7

Immunology and Microbiology Devices

1

No

CA, FL, NH, PA, SD, TX, WA

Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays.

catalog # CA 1725, lot # 04164

Clinical Chemistry and Clinical Toxicology Devices

1

No

Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, Israel,

DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.

Ref No. 68100E, Lot # 113300B.

Clinical Chemistry and Clinical Toxicology Devices

1

No

MI, IL, AZ, MN, OR, GA, MO, Sweden, Germany, Great Britain, Spain, Belgium, Italy, Norway, Brazil, Hungary, Switzerland

DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A., Lot # 113300B.