Z-0100-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- July 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5980 units
Product Description
Access Thyroglobulin Calibrators
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.
Distribution Pattern
worldwide except US, Canada, and China
Code Information
UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940