FDA-Device2015-10-14Class II
Access Free T3 Reagent Kit, P/N 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.
Beckman Coulter Inc.
Hazard
Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.
Sold states
Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam.
Affected count
16,648 units total (1874 units in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Access Free T3 Reagent Kit, P/N 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0110-2016Don't want to check this manually?
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