Device product
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Z-0239-2016
Product summary
- Event
- Event 72408
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,406 units total (1,660 units)
- Official record key
device-enforcement:Z-0239-2016
Official wording
Reason: Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Code information: 595027 595029
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.
Derived failure modes
-
Unknown
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.