Devices

Device Recall Access 2; Immunoassay System Analyzer

Model / Serial
Part Number 81600N. Serial Numbers 508957, 508963, 508964.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
Product Description
Access 2 Immunoassay System Analyzer. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall Access 2; Immunoassay System Analyzer

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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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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