Recall Z-0239-2016 ยท DHX System, Test, Carcinoembryonic Antigen
Beckman Coulter Inc.
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
| Date | Nov 6, 2015 (initiated Oct 13, 2015) |
| Status | Terminated |
| 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://ww |
| 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, Mex |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031270 | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc., May 6, 2003 |