FDA-Device2013-06-05Class II
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Beckman Coulter Inc.
Hazard
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.
Sold states
Worldwide Distribution-USA Nationwide and countries of: AU, CA, DE, ES, GB, IT, PT, and JP.
Affected count
108 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1430-2013Don't want to check this manually?
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