Beckman Coulter Inc. recalls Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human

Recalled November 18, 2015 · FDA recall Z-0239-2016 · Beckman Coulter

Hazard

Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. · FDA Class II

Units

11,406 units total (1,660 units)

Sold at

Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Egypt, France, Germany, Ghana, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Mexico, Morocco, Myanmar, Netherlands, Pakistan, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

Description

Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.

Product

Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.

Manufacturer(s)

Beckman Coulter Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →