FDA-Device2023-10-18Class II
Access Thyroglobulin Calibrators
Beckman Coulter, Inc.
Hazard
It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
Sold states
worldwide except US, Canada, and China
Affected count
5980 units
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Access Thyroglobulin Calibrators
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2024Don't want to check this manually?
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