Access Total T4 Calibrator — Class II medical device recall Z-1922-2026
Ongoing recall by Beckman Coulter, Inc., reported 2026-04-29, distributed nationwide. Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI
| Recall number | Z-1922-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2026-03-16 |
| Classified | 2026-04-22 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BD, BO, BR, CA, CH, CN, CZ, DE, DK, EG, ES, GR, HK, HR, ID, IE, IN, IT, JP, KR, LB, MX, NG, NL, NP, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SG, SK, SV, TH, TR, TW, VN |
| UPC / GTIN / UDI-DI | 15099590225872 |
| Lot numbers | 538729, 538815, 538898, 539107, 539243 |
| Model numbers | 33805 |
Product
Access Total T4 Calibrator, Catalog No. 33805
Reason for recall
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
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-1922-2026. 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.