Z-0100-2024 Class II Ongoing
FDA device recall Z-0100-2024 was initiated by Beckman Coulter, Inc. on July 6, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 5980 units.
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