PlainRecalls
FDA Devices Moderate Class II Terminated

Access Immunoassay Systems Reaction Vessels. 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.

Reported: December 25, 2013 Initiated: October 2, 2013 #Z-0519-2014

Product Description

Access Immunoassay Systems Reaction Vessels. 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.

Reason for Recall

Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System "Wash Carousel Motion Errors" with specific lots of Access System Reaction Vessels (RVs). I

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
16,154 units
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.
Location
Brea, CA

Frequently Asked Questions

What product was recalled? ▼
Access Immunoassay Systems Reaction Vessels. 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.. Recalled by Beckman Coulter Inc.. Units affected: 16,154 units.
Why was this product recalled? ▼
Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System "Wash Carousel Motion Errors" with specific lots of Access System Reaction Vessels (RVs). I
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0519-2014.

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