Z-0239-2016Class II

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

Name: Z-0239-2016 Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels...
Creator: Beckman Coulter Inc.
Published: 2015-10-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-10-13 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum on 2015-10-13. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0239-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-13
Posted: 2015-11-06
Terminated: 2016-04-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Product code: DHX System, Test, Carcinoembryonic Antigen
Reason for recall: Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
FDA 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 in commerce: 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.
Product codes and lots: 595027 595029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0239-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0239-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

Product code DHX

K031270Class IIAccess Cea Reagents for Use on the Access Immunoassay SystemsBeckman Coulter, Inc. / cleared 2003-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)