FDA Device recall Z-1303-2024
Access Total T4, REF 33800, IVD, thyroxine reagent assay
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of Access Total T4, REF 33800, IVD, thyroxine reagent assay by Beckman Coulter, citing four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1303-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-08 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Reason
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
Identifiers
| code_info | Lot numbers: 338555, exp. 31 JUL 2024; 338556, exp. 31 AUG 2024; 338734, exp. 30 SEP 2024; and 338958, exp. 31 OCT 2024; UDI-DI 15099590225742. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1303-2024%22
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