Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
FDA Recall Z-0239-2016 · Posted 2015-11-06
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeDHX
Date Initiated2015-10-13
Date Terminated2016-04-13
Product Quantity11,406 units total (1,660 units)
Reason for Recall
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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