Access Total T3 — Class II medical device recall Z-2635-2017
Terminated recall by Beckman Coulter Inc., reported 2017-07-05, distributed in GA, GU, PR. The Access immunoassays are susceptible to biotin interference.
| Recall number | Z-2635-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-05-09 |
| Classified | 2017-06-28 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2018-03-30 |
| Distributed | GA, GU, PR |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LK, LT, MA, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SK, SV, TH, TN, TR, TW, UY, VE, VN |
| Model numbers | 33830 |
Product
Access Total T3, A34435H, Catalog No. 33830
Reason for recall
The Access immunoassays are susceptible to biotin interference.
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-2635-2017. 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.