Recall Z-0239-2016
Beckman Coulter Inc. · initiated October 13, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Codes / lots: 595027 595029
Reason for recall
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-0239-2016
- Initiated
- October 13, 2015
- Posted by FDA
- November 6, 2015
- Terminated
- April 13, 2016
- Product code
- DHX – System, Test, Carcinoembryonic Antigen
- 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…
- Recalling firm
- Beckman Coulter Inc., Brea, CA