Devices

Access Immunoassay Systems

Model / Serial
DxI software versions: 4.2 and 4.2.1. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- United States and Canada.
Product Description
UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1. || In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Access Immunoassay Systems

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

96 devices with a similar name

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Device Recall Access Immunoassay Systems, Discrete photometric chemistry analyzer

Model / Serial
Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
Manufacturer
Beckman Coulter Inc

Access Immunoassay Systems Assay Protocol: Dil-AFP.

Model / Serial
All lot numbers.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Access Immunoassay Systems Assay Protocol: Dil-AFP.
Manufacturer
Beckman Coulter Inc

UniCel DxI 600 Access Immunoassay Systems, UniCel DxI 800 Access Immunoassay Systems, UniCel DxC ...

Model / Serial
Manufacturer
Beckman Coulter Inc.

UniCel DxI Access Immunoassay Systems Reaction Vessels

Model / Serial
Product Description
In-vitro diagnostics
Manufacturer
Beckman Coulter

Access Immunoassay Systems HAV Ab Reagent Kit

Model / Serial
Product Description
In-vitro diagnostics
Manufacturer
Beckman Coulter

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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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