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  • Dispositivo 98
  • Fabricante 6
  • Evento 124969
  • Implante 0
ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).Product Code: GT-ABC1/2AULot Number: 3004753Expiration Date: 15 Nov 2017ARTG Number: 236406
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
Pak Lx Assay
  • Modelo / Serial
    Pak Lx AssayProduct Code: GT-PLXLot Number: 3003658with Conjugate Lot: 3003881Lot Number: 3004022with Conjugate Lot: 3003881ARTG Number: 217307
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Pak Lx Assay
FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An ...
  • Modelo / Serial
    FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)Product Code: BM-MX005-sLot Number: LE124535Expiry: 31 Jan 2018ARTG Number: 198370
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de FIDS dsDNA Kit (used for the detection and monitoring of Systemic Lupus Erythematosis (SLE)). An in vitro diagnostic medical device (IVD)
LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: TL628921Lot Number: 10235BProbes affected: 380, 382, 384, 385ARTG Number: 217872
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD)
ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD) Product Code: IC7696-10Lot Numbers:1525909 and 1525812 ARTG Number: 197980
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD)
LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).Code Number: TL628215Lot Number: 3002350Expiration Date: 15 Nov 2015ARTG Number: 217870
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de LIFECODES LifeScreen Deluxe (LMX). An in vitro diagnostic medical device (IVD).
PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Dev...
  • Modelo / Serial
    PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Device (IVD).Lot Numbers: 3001992 & 3002227ARTG Number: 217308
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Device (IVD).
OriGen Syringe DMSO (Used for Research Use Only)
  • Modelo / Serial
    OriGen Syringe DMSO (Used for Research Use Only)Multiple part numbers and lot numbers affected
  • Manufacturer
    Diagnostic Solutions Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de OriGen Syringe DMSO (Used for Research Use Only)
EliA Sample Diluent
  • Modelo / Serial
    EliA Sample DiluentArt. No. 83-1023-01Lot Numbers: JM3Y, JS0B, JP87, JK5N, JU9CBottle Lots: BVXDR/JM3W, BVXDT/JS0A, BVXDS/JP83, BVXDP/JK5M, BVXDU/JU9BARTG Number: 229543
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de EliA Sample Diluent
ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).Lot Numbers: AAS0D (exp 31 Mar 2012)AAS0E (exp 31 Mar 2013)AAS0F (exp 31 May 2014)AAS0G (exp 30 Nov 2014)AAS0H (exp 31 Jan 2015)AASG1 (exp 31 Jul 2016)AASG2 (exp 30 Jun 2016)AASG3 (exp 30 Jun 2018)ARTG Number:186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).
IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medic...
  • Modelo / Serial
    IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medical device (IVD).Reference Number: E-KR-480Lot Numbers: 013A & 016AARTG Number: 274979
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medical device (IVD).
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).Kit Item Number: CR2003Lot Numbers: 161019161504NZ & 161007110553JGARTG Number: 272537
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).
ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. A...
  • Modelo / Serial
    ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. An in vitro diagnostic medical device (IVD).ImmunoCAP Specific IgG/IgG4 i1 Control HArticle Number: 10-9475-01Vial Lots: with expiry date up to July 2017 (C6XAX or older)ImmunoCAP Allergen i1, Honey bee venomArticle Number: 10-4143-01Lot Numbers: 389B7, 389B8, 389B9, 389BA & 389BB ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ImmunoCAP Specific IgG/IgG4 i1 Control H when used with ImmunoCAP Allergen i1, Honey bee venom. An in vitro diagnostic medical device (IVD).
Coxiella burnetii IFA IgG Kit
  • Modelo / Serial
    Coxiella burnetii IFA IgG KitReference Number: PCOBUGKit Lot Number: 15C304Slide Lot Number: 15C403ARTG Number: 212957An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Coxiella burnetii IFA IgG Kit
Cell Marque Rabbit Monoclonal Antibody. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Cell Marque Rabbit Monoclonal Antibody. An in vitro diagnostic medical device (IVD)Product Code: S100A1 (EP184)Affected products: Cell Marque S100A1 rabbit EP184 0.1 concentrate Catalogue Number: 408R-14Cell Marque S100A1 rabbit EP184 1 concentrateCatalogue Number: 408R-16Lot numbers: 1335409A to1335409FARTG Number: 239099
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Cell Marque Rabbit Monoclonal Antibody. An in vitro diagnostic medical device (IVD)
ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro di...
  • Modelo / Serial
    ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro diagnostic medical device (IVD)Kit Article Number: 10-9530-01Kit Lot Numbers: JBWA, JEXGVial Lot Number: CYYACARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ImmunoCAP Specific IgE Control H (used to aid the diagnosis of allergy or asthma). An in vitro diagnostic medical device (IVD)
EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).EliA IgG Conjugate 50Article Number: 83-1017-01EliA IgG Conjugate 200Article Number: 83-1018-01EliA IgG ConjugateArticle Number: 83-1005-01 EliA IgG ConjugateArticle Number: 83-1002-01Multiple Lots and Kits affectedARTG Number: 229585
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).
QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPC
  • Modelo / Serial
    QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPCatalogue Number: 146521Production Lot: HX78Expiry Date: 24/11/2016QuikRead go wrCRP+HbCatalogue Number: 146255Production Lot: HX85Expiry Date: 31/01/2017ARTG Number: 206301
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de QuikRead go wrCRP and QuikRead go wrCRP+Hb QuikRead go wrCRPC
ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)
  • Modelo / Serial
    ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)Part Number: 10-9475-01Lot Numbers: All lot numbers when used in combination with ImmunoCAP Allergen i1Honey bee venom art. No 14-4143-01, lot numbers 389B7 and 389B8ARTG Number: 186054
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD)
EliA SmDP Well
  • Modelo / Serial
    EliA SmDP WellPart Number: 14-562-01Lot Numbers: 0018 and 0019Expiry Dates 30 November 2016 and 31 March 2017ARTG Number: 229585
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de EliA SmDP Well
Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD) Part Number: 12-3800-01 ARTG Number: 192561
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD)
Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)Catalogue Numbers: CM235R-17 and CM235R-18Lot Number: 1221903
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)
KWIK-QC Acid Fast Stain Slides (Microbiology quality control slides). An in vitro diagnostic medi...
  • Modelo / Serial
    KWIK-QC Acid Fast Stain Slides (Microbiology quality control slides). An in vitro diagnostic medical device (IVD)Product Code: SL42-10Lot Number: 4242Expiry Date: 20/06/2014
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de KWIK-QC Acid Fast Stain Slides (Microbiology quality control slides). An in vitro diagnostic medical device (IVD)
CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrate and CD7 Mouse Monoclonal Antibody (MRQ-12)...
  • Modelo / Serial
    CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrate and CD7 Mouse Monoclonal Antibody (MRQ-12) 0.5ml concentrate (T-cell markers used in immunohistochemistry). An in vitro diagnostic medical device (IVD)CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrateLot Number: 8109Catalogue Number: 107M-16CD7 Mouse Monoclonal Antibody (MRQ-12) 0.5ml concentrateLot Number: 8109Catalogue Number: 107M-15
  • Manufacturer
    Abacus ALS Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrate and CD7 Mouse Monoclonal Antibody (MRQ-12) 0.5ml concentrate (T-cell markers used in immunohistochemistry). An in vitro diagnostic medical device (IVD)CD7 Mouse Monoclonal Antibody (MRQ-12) 1ml concentrate
E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode)
  • Modelo / Serial
    E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode)Catalogue: MG0100LSLot Numbers: 131509, 131946ARTG Number: 192262
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Manufacturer
    Big Green Surgical Company Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode)
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