Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Reported: November 18, 2015 Initiated: October 13, 2015 #Z-0239-2016
Product Description
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Reason for Recall
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units 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, 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.. Recalled by Beckman Coulter Inc.. Units affected: 11,406 units total (1,660 units).
Why was this product recalled? ▼
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2015. Severity: Moderate. Recall number: Z-0239-2016.
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