Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human s
FDA device recall Z-0239-2016 · posted 2015-11-06 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
- Action taken
- 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
- Status
- Terminated
- Product code
- DHX
- Quantity affected
- 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, Gree
- Date initiated
- 2015-10-13
- Date posted
- 2015-11-06
- Date terminated
- 2016-04-13
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (K031270) | Beckman Coulter, Inc. | 2003-05-06 |