Access Thyroglobulin Assay — Class II medical device recall Z-2733-2015
Terminated recall by Beckman Coulter Inc., reported 2015-09-09, distributed nationwide. Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10
| Recall number | Z-2733-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2015-07-28 |
| Classified | 2015-09-03 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2016-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DZ, EG, ES, FR, GB, GR, HK, HN, HU, IE, IL, IN, IT, JP, KR, LB, LT, MA, MX, NZ, OM, PH, PT, QA, RS, SA, SE, SG, SK, TR, TW, VN |
| Lot numbers | 430969, 431990, 434727, 522896, 523251 |
| Model numbers | 33860 |
| Expiration dates | 2016-10-31 |
Product
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
Reason for recall
Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL.
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-2733-2015. 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.