FDA-Device2024-03-27Class II
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Beckman Coulter, Inc.
Hazard
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
Sold states
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan, Mexico, Namibia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, U.A.E, Vietnam, and Zimbabwe.
Affected count
64,009 kits
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2024Don't want to check this manually?
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