PlainRecalls
FDA Devices Moderate Class II Terminated

AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.

Reported: June 5, 2013 Initiated: April 26, 2013 #Z-1430-2013

Product Description

AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.

Reason for Recall

Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
108 units
Distribution
Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
Location
Brea, CA

Frequently Asked Questions

What product was recalled?
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.. Recalled by Beckman Coulter Inc.. Units affected: 108 units.
Why was this product recalled?
Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 5, 2013. Severity: Moderate. Recall number: Z-1430-2013.