FDA Device recall Z-0100-2024
Access Thyroglobulin Calibrators
- FDA Device
- Class II
- ongoing
- Published 2023-10-18
On 2023-10-18 the FDA classified a Class II recall of Access Thyroglobulin Calibrators by Beckman Coulter, citing 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 wil….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0100-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-06 |
| Published | 2023-10-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
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.
Identifiers
| code_info | UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0100-2024%22
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