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Beckman Coulter, Inc. recalls Access Thyroglobulin Calibrators
Recalled October 18, 2023 · FDA recall Z-0100-2024 · Beckman Coulter
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. · FDA Class II
Units
5980 units
Sold at
worldwide except US, Canada, and China
Description
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.
Product
Access Thyroglobulin Calibrators
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →