Home / Recalls / Medical Devices
Beckman Coulter Inc. recalls Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay
Recalled June 18, 2014 · FDA recall Z-1737-2014 · Beckman Coulter
Hazard
Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws. · FDA Class II
Units
82 units
Sold at
Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.
Description
Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.
Product
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →