Recall archive / FDA device enforcement
Access Thyroglobulin Calibrators — FDA record Z-0100-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Access Thyroglobulin Calibrators
- 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.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 5980 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0100-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
worldwide except US, Canada, and China
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 18, 2023
- Recall initiation date
- Jul 6, 2023
- Center classification date
- Oct 11, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.