Beckman Coulter Recalls Access Immunoassay Reaction Vessels Due to Motion Errors
Beckman Coulter is recalling Access Immunoassay Reaction Vessels due to intermittent wash carousel motion errors affecting specific lots.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter is initiating a recall for Access Immunoassay Systems Reaction Vessels. This recall includes the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System. The affected units are identified by Part Number 81901 and Lot Numbers 13181168-13341170.
The recall is being conducted because Beckman Coulter has observed an intermittent increase in "Wash Carousel Motion Errors" associated with specific lots of these 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.
A total of 16,154 units were distributed worldwide, including nationwide in the USA and internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, Jordan, Malaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam. Users should contact Beckman Coulter for further instructions regarding the recall.
The recalled product
- Product
- 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.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 16,154
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number 81901
- Lot Numbers: 13181168-13341170.
Distribution
Distributed nationwide across the United States.
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