Device product
Access Thyroglobulin Calibrators
Z-0100-2024
Product summary
- Event
- Event 92670
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5980 units
- Official record key
device-enforcement:Z-0100-2024
Official wording
Reason: 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.
Code information: UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940
Distribution pattern: worldwide except US, Canada, and China
Derived failure modes
-
Unknown
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.