FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
- Recall number
- Z-0239-2016
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
- Status
- Terminated
- Initiated
- 2015-10-13
- Posted
- 2015-11-06
- Terminated
- 2016-04-13
- Reason
- Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Medical Device Recall letter dated 10/13/15 was sent to all customers who purchased the Access CEA Reagent Kit to inform them that Beckman Coulter has determined that the Access CEA reagent packs (P/N 33200) were filled incorrectly. The packs contain insufficient quantity of reagents in one of the pack wells. The letter informs the customers of the impact and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Technical Support at http://www.beckmancoulter.com, (800) 854-3633 in the US and Canada. Customers outside of the US and Canada are instructed to contact their local Beckman Coulter representative.
- Quantity
- 11,406 units total (1,660 units)
- Distribution
- 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.
- Lot, serial or model codes
- 595027 595029
- 510(k) numbers
- ["K031270"]
- PMA numbers
- not on file
- Product code
- DHX
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28