International Medical Devices Database

Model / Serial
Eon, Eon Mini and Brio Implantable Pulse Generator (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)Eon Implantable Pulse Generator (IPG)Product Code 64-3716 ARTG Number: 127126Eon Mini IPGProduct Code: 65-3788 ARTG Number: 154912Brio IPGProduct code 65-6788 ARTG Number: 164510
Manufacturer
St Jude Medical Australia Pty Ltd
1 Event
- Recall of Eon, Eon Mini and Brio Implantable Pulse Generator (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)

Afinion AS100 Analyser, CRP and CRP Control; An in vitro diagnostic medical device (IVD)

Model / Serial
Afinion AS100 Analyser, CRP and CRP Control; An in vitro diagnostic medical device (IVD)Afinion AS100 AnalyserREF: 1115027, 1115173, 1115174, 1115176, 1115172, 1115175, 1115507, 1115419 & 1115516Afinion CRPREF: 1115013, 1115014 & 1115377Afinion CRP ControlREF: 1114993
Manufacturer
Inverness Medical Innovations Australia Pty Ltd
1 Event
- Recall of Afinion AS100 Analyser, CRP and CRP Control; An in vitro diagnostic medical device (IVD)

ARCHITECT Toxo IgG; An in vitro diagnostic medical device (IVD)

Model / Serial
ARCHITECT Toxo IgG; An in vitro diagnostic medical device (IVD)List Number: 6C19-25Lot Numbers: 15070LI00
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Recall of ARCHITECT Toxo IgG; An in vitro diagnostic medical device (IVD)

Eon Mini and Brio Implantable Pulse Generators (IPG) (Implantable Spinal Cord and Deep Brain Stim...

Model / Serial
Eon Mini and Brio Implantable Pulse Generators (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)Eon MiniProduct Code: 65-3788ARTG Number: 154912Brio IPG Product Code: 65-6788ARTG Number: 164510
Product Classification
Neurological Devices
Manufacturer
St Jude Medical Australia Pty Ltd
1 Event
- Recall of Eon Mini and Brio Implantable Pulse Generators (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)

Armada 35 and Armada 35LL percutaneous transluminal angioplasty (PTA) catheter (balloon dilation ...

Model / Serial
Armada 35 and Armada 35LL percutaneous transluminal angioplasty (PTA) catheter (balloon dilation catheter)All part numbers are affectedAll lot numbers up to and including 783705ARTG Number: 191827
Product Classification
Cardiovascular Devices
Manufacturer
Abbott Vascular Division of Abbott Australasia Pty Ltd
1 Event
- Recall of Armada 35 and Armada 35LL percutaneous transluminal angioplasty (PTA) catheter (balloon dilation catheter)

ARCHITECT HAVAb-IgG Assay (Indicated as an aid in the diagnosis of hepatitis A viral infection or...

Model / Serial
ARCHITECT HAVAb-IgG Assay (Indicated as an aid in the diagnosis of hepatitis A viral infection or detection of IgG anti-HAV ). An in-vitro diagnostic medical deviceList Numbers: 6C29-20 and 6C29-25Multiple Lot Numbers
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Recall of ARCHITECT HAVAb-IgG Assay (Indicated as an aid in the diagnosis of hepatitis A viral infection or detection of IgG anti-HAV ). An in-vitro diagnostic medical device

Clinical Chemistry Phenobarbital Reagent. An in vitro diagnostic medical device (IVD)

Model / Serial
Clinical Chemistry Phenobarbital Reagent. An in vitro diagnostic medical device (IVD)List Number: 1E08Lot Numbers: 52803UN12 (expired), 62299UN12 & 85773UN12An in vitro diagnostic medical device (IVD)
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Recall of Clinical Chemistry Phenobarbital Reagent. An in vitro diagnostic medical device (IVD)

ARCHITECT Active-B12 (Holotranscobalamin). An in vitro diagnostic medical device (IVD)

Model / Serial
ARCHITECT Active-B12 (Holotranscobalamin). An in vitro diagnostic medical device (IVD)List Numbers: 3P24-25 / 3P24-35Lot Numbers: 10112UP00, 10113UP00 and 1013UP00
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Recall of ARCHITECT Active-B12 (Holotranscobalamin). An in vitro diagnostic medical device (IVD)

ARCHITECT Testosterone Reagent, ARCHITECT Testosterone Calibrators and ARCHITECT Testosterone Con...

Model / Serial
ARCHITECT Testosterone Reagent, ARCHITECT Testosterone Calibrators and ARCHITECT Testosterone Controls. An in vitro diagnostic medical device (IVD)List numbers: 7K73-20, 7K73-25, 7K73-01, 7K73-10Multiple serial / lot numbers
Manufacturer
Abbott Australiasia Pty Ltd (Molecular Division)
1 Event
- Recall of ARCHITECT Testosterone Reagent, ARCHITECT Testosterone Calibrators and ARCHITECT Testosterone Controls. An in vitro diagnostic medical device (IVD)

Abbott Molecular m 2000sp instrument. An in vitro diagnostic medical device (IVD)

Model / Serial
Abbott Molecular m 2000sp instrument. An in vitro diagnostic medical device (IVD) List Number: 09K14This issue is not serial number specific
Manufacturer
Abbott Australasia Pty Ltd Diagnostic Division
1 Event
- Recall of Abbott Molecular m 2000sp instrument. An in vitro diagnostic medical device (IVD)

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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