medical Class II Updated 2023-10-18

Beckman Coulter, Inc. recalls Access Thyroglobulin Calibrators

Recalled Product

Access Thyroglobulin Calibrators


Hazard / Issue

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.

Issued by

FDA

Distribution: worldwide except US, Canada, and China
Lot/Code Info: UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940
View official government recall

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