Devices

Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD) Used with systems: Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.

Model / Serial
Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD)Used with systems: Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems. Part Number: 33200Lot Numbers: 595027 and 595029Expiry Date: 15 Feb 2016 and 28 Feb 2016ARTG Number: 213975
Manufacturer
Beckman Coulter Australia Pty Ltd
1 Event
- Recall of Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD) Used with systems: Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.

Manufacturer

Beckman Coulter Australia Pty Ltd

Manufacturer Parent Company (2017)
Danaher Corporation
Source
DHTGA

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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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