FDA Enforcement
Class II
Terminated
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.
Recall: Z-0984-2014
·
Reported February 26, 2014
Enforcement
- Recall Number
- Z-0984-2014
- Event ID
- 66958
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Beckman Coulter Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 26, 2014
- Initiation Date
- November 26, 2013
- Classification Date
- February 16, 2014
- Termination Date
- July 27, 2014
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232, United States
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.
Reason
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
Code Info
Part Number 81600N. Serial Numbers 508957, 508963, 508964.
Distribution
Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
Quantity
3 units