FDA-Device2014-11-12Class II
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter Inc.
Hazard
Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.
Sold states
Worldwide Distribution - US Nationwide in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Germany, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States including Puerto Rico, Venezuela, and Vietnam.
Affected count
1,519 units total (403 units total)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0175-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief