Beckman Coulter Inc. recalls Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human…
- Recall date
- October 13, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0239-2016
- FDA classification
- Class II
- Brand / firm
- Beckman Coulter Inc.
- Sold / distributed
- 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, Mex…
Why it was recalled
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Get recall alerts
Free email alert whenever Beckman Coulter Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Beckman Coulter Inc.