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Diasorin Inc.

36 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of recall (Z-0677-2025)Diasorin Inc.2024-12-12
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 recall (Z-0815-2024)Diasorin Inc.2024-01-25
DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO recall (Z-1464-2015)Diasorin Inc.2015-04-20
ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed recall (Z-1744-2011)Diasorin Inc.2011-03-22
GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 recall (Z-1914-2010)Diasorin Inc.2010-06-28
DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern recall (Z-0922-2010)Diasorin Inc.2010-03-02
Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Sp recall (Z-1042-2009)Diasorin Inc.2009-03-30
LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, St recall (Z-1240-2008)Diasorin Inc.2008-05-07
25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Mi recall (Z-1237-2007)Diasorin Inc.2007-09-20
DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative a recall (Z-0755-2007)Diasorin Inc.2007-04-24
DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitativ recall (Z-0748-2007)Diasorin Inc.2007-04-14
1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitam recall (Z-0707-2007)Diasorin Inc.2007-04-03
The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. tha recall (Z-0557-06)Diasorin Inc.2006-02-23
ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 recall (Z-1576-05)Diasorin Inc.2005-10-01
DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. recall (Z-0927-05)Diasorin Inc.2005-06-25
Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration Sy recall (Z-0807-05)Diasorin Inc.2005-05-10
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. recall (Z-0784-05)Diasorin Inc.2005-04-28
DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatiti recall (Z-0776-05)Diasorin Inc.2005-04-27
Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate read recall (Z-0702-05)Diasorin Inc.2005-04-13
Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 whi recall (Z-0703-05)Diasorin Inc.2005-04-13
DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of recall (Z-0704-05)Diasorin Inc.2005-04-13
DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D recall (Z-0705-05)Diasorin Inc.2005-04-13
DiaSorin Analyte Specific Reagent recall (Z-0706-05)Diasorin Inc.2005-04-13
Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 read recall (Z-0672-05)Diasorin Inc.2005-04-06
Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate recall (Z-0673-05)Diasorin Inc.2005-04-06
Data reduction program written for a specific automated microtiter plate instrument (Bio-T recall (Z-0674-05)Diasorin Inc.2005-04-06
Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 1 recall (Z-0675-05)Diasorin Inc.2005-04-06
PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titrat recall (Z-0676-05)Diasorin Inc.2005-04-06
DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C recall (Z-0658-05)Diasorin Inc.2005-03-29
DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of anto recall (Z-0632-05)Diasorin Inc.2005-03-18
ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of spec recall (Z-0633-05)Diasorin Inc.2005-03-18
DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwat recall (Z-0634-05)Diasorin Inc.2005-03-18
Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 4 recall (Z-0636-05)Diasorin Inc.2005-03-18
LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E. recall (Z-0637-05)Diasorin Inc.2005-03-18
Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 recall (Z-0638-05)Diasorin Inc.2005-03-18
Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in recall (Z-0572-05)Diasorin Inc.2005-03-08

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