Access Free T3 Assay — Class II medical device recall Z-2108-2016
Terminated recall by Beckman Coulter Inc., reported 2016-07-06, distributed in GU, PR. Demonstrate an upward shift in patient results.
| Recall number | Z-2108-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-06-08 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2017-04-18 |
| Distributed | GU, PR |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BO, BR, CA, CH, CN, CO, CR, CZ, DE, DK, DZ, EC, EE, EG, ES, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KW, LB, LT, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SK, SV, TH, TR, TW, UY, VE, VN, ZA |
| Model numbers | A13422 |
Product
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Reason for recall
Demonstrate an upward shift in patient results.
Machine access
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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.