Access Total T4 — Class II medical device recall Z-1303-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-03-27, distributed nationwide. Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may
| Recall number | Z-1303-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-02-08 |
| Classified | 2024-03-15 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BD, BH, BO, BR, CA, CN, CZ, DK, EG, ES, GR, HK, HR, IN, MX, PA, PE, PH, PK, PL, PT, QA, RS, RU, SA, SG, SK, SV, TH, TR, TW, VN |
| Quantity | 64,009 kits |
| UPC / GTIN / UDI-DI | 15099590225742 |
| Lot numbers | 338555, 338556, 338734, 338958 |
| Model numbers | 33800 |
| Expiration dates | 2024-07-31, 2024-08-31, 2024-09-30, 2024-10-31 |
Product
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Reason for recall
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed 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-1303-2024. 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.