Home / Recalls / Medical Devices
Beckman Coulter Inc. recalls UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative,
Recalled October 1, 2014 · FDA recall Z-2687-2014 · Beckman Coulter
Hazard
Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi · FDA Class II
Units
236 units total (70 units in US)
Sold at
Nationwide in US and worldwide: Canada, China, Colombia, Croatia, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam.
Description
Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi
Product
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →