UniCel DxI 600 Access 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.
Reported: February 26, 2014 Initiated: November 26, 2013 #Z-0985-2014
Product Description
UniCel DxI 600 Access 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 for Recall
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 1 unit
- Distribution
- Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
UniCel DxI 600 Access 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.. Recalled by Beckman Coulter Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-0985-2014.
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