Access Thyroglobulin Calibrators — Class II medical device recall Z-0100-2024
Ongoing recall by Beckman Coulter, Inc., reported 2023-10-18. It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator ca
| Recall number | Z-0100-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2023-07-06 |
| Classified | 2023-10-11 |
| Reported by FDA | 2023-10-18 |
| Countries outside the US | CA, CN |
| Quantity | 5,980 units |
| UPC / GTIN / UDI-DI | 15099590227166 |
| Lot numbers | 233806, 234171, 234355, 234443, 234444, 234617, 337940 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0100-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.