Beckman Coulter Inc. recalls Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassa

Recalled July 6, 2016 · FDA recall Z-2108-2016 · Beckman Coulter

Hazard

Demonstrate an upward shift in patient results. · FDA Class II

Units

205,744 kits total (13,358 kits in US)

Sold at

Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Ghana, Gibraltar, Greece, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, Zimbabwe

Description

Demonstrate an upward shift in patient results.

Product

Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.

Manufacturer(s)

Beckman Coulter Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →