FDA-Device2015-11-18Class II
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Beckman Coulter Inc.
Hazard
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Sold states
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.
Affected count
11,406 units total (1,660 units)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0239-2016Don't want to check this manually?
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