Beckman Coulter, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0100-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Access Thyroglobulin Calibrators

Product Classification:

Class II

Date Initiated: July 6, 2023

Date Posted: October 18, 2023

Recall Number: Z-0100-2024

Event ID: 92670

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 5980 units

Code Information:

UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940

Distribution Pattern:

worldwide except US, Canada, and China

Voluntary or Mandated:

Voluntary: Firm initiated