International Medical Devices Database

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ENDOSCOPE DISINFECTOR

Modelo / Serial
Model Catalog: DSD-110-HU0109 (Lot serial: )
Descripción del producto
ENDOSCOPE DISINFECTOR DSD-110-HU0109
Manufacturer
VANTAGE ENDOSCOPY INC.
1 Event
- Retiro De Equipo (Recall) de ENDOSCOPE DISINFECTOR

ENDOSCOPE DISINFECTOR

Modelo / Serial
Model Catalog: DSD-110-HU0109 (Lot serial: NA)
Descripción del producto
ENDOSCOPE DISINFECTOR
Manufacturer
VANTAGE ENDOSCOPY INC.
1 Event
- Retiro De Equipo (Recall) de ENDOSCOPE DISINFECTOR

G7 AUTOMATED GLYCOHEMOGLOBIN SYSTEM - INSTRUMENTS

Modelo / Serial
Model Catalog: 019327 (Lot serial: ); Model Catalog: 021560 (Lot serial: N/A); Model Catalog: 021560 (Lot serial: unavailable)
Descripción del producto
Tosoh HLC-723G7
Manufacturer
SOMAGEN DIAGNOSTICS INC.
1 Event
- Retiro De Equipo (Recall) de G7 AUTOMATED GLYCOHEMOGLOBIN SYSTEM - INSTRUMENTS

NICHOLS ADVANTAGE SPECIALTY SYSTEM 25- HYDROXYVITAMIN D (25-OH-D)ASSAY

Modelo / Serial
Model Catalog: (Lot serial: )
Descripción del producto
HYDROXYVITAMIN D ASSAY
Manufacturer
SOMAGEN DIAGNOSTICS INC.
1 Event
- Retiro De Equipo (Recall) de NICHOLS ADVANTAGE SPECIALTY SYSTEM 25- HYDROXYVITAMIN D (25-OH-D)ASSAY

G7 AUTOMATED GLYCOHEMOGLOBIN SYSTEM - HEMOGLOBIN F&A2 CALIBRATOR

Modelo / Serial
Model Catalog: 0020019 (Lot serial: BCAL05R)
Descripción del producto
G7 Automtated Glycohemoglobin System - F & A2 Calibrators
Manufacturer
SOMAGEN DIAGNOSTICS INC.
1 Event
- Retiro De Equipo (Recall) de G7 AUTOMATED GLYCOHEMOGLOBIN SYSTEM - HEMOGLOBIN F&A2 CALIBRATOR

CALIBRATION VERIFICATION ASSESSMENT (CVA)

Modelo / Serial
Model Catalog: (Lot serial: 8287)
Descripción del producto
Calibration Verification Assessment
Manufacturer
SOMAGEN DIAGNOSTICS INC.
1 Event
- Retiro De Equipo (Recall) de CALIBRATION VERIFICATION ASSESSMENT (CVA)

IMMUNOCARD MYCOPLASMA

Modelo / Serial
Model Catalog: 709030 (Lot serial: 709030C713); Model Catalog: 709030 (Lot serial: 709030C714)
Descripción del producto
ImmunoCard Mycoplasma
Manufacturer
SOMAGEN DIAGNOSTICS INC.
1 Event
- Retiro De Equipo (Recall) de IMMUNOCARD MYCOPLASMA

ACCURUN 51 MULTI-MARKER HEPATITIS POSITIVE CONTROL 1

Modelo / Serial
Model Catalog: 2000-0041 (Lot serial: Batch 10164524); Model Catalog: 2000-0040 (Lot serial: Batch 10164524); Model Catalog: A51-5001 (Lot serial: Batch 10164524); Model Catalog: A51-5005 (Lot serial: Batch 10164524); Model Catalog: 2000-0040 (Lot serial: Batch 10231486); Model Catalog: 2000-0041 (Lot serial: Batch 10231486); Model Catalog: A51-5001 (Lot serial: Batch 10231486); Model Catalog: A51-5005 (Lot serial: Batch 10231486); Model Catalog: 2000-0040 (Lot serial: Batch 10164525); Model Catalog: 2000-0041 (Lot serial: Batch 10164525); Model Catalog: A51-5001 (Lot serial: Batch 10164525); Model Catalog: A51-5005 (Lot serial: Batch 10164525); Model Catalog: 2000-0040 (Lot serial: Batch 10231487); Model Catalog: 2000-0041 (Lot serial: Batch 10231487); Model Catalog: A51-5001 (Lot serial: Batch 10231487); Model Catalog: A51-5005 (Lot serial: Batch 10231487)
Descripción del producto
ACCURUN 51 Multi-Marker Hepatitis Positive Control;ACCURUN 51 Multi-Marker Hepatitus Positive Control
Manufacturer
SOMAGEN DIAGNOSTICS INC.
1 Event
- Retiro De Equipo (Recall) de ACCURUN 51 MULTI-MARKER HEPATITIS POSITIVE CONTROL 1

STARRSED INVERSA 24M

Modelo / Serial
Model Catalog: BANG109000 (Lot serial: S/N 044795)
Descripción del producto
StaRRsed Inversa 24M
Manufacturer
SOMAGEN DIAGNOSTICS INC.
1 Event
- Retiro De Equipo (Recall) de STARRSED INVERSA 24M

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)

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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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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