T3F — Class II medical device recall Z-0868-2014
Terminated recall by Siemens Healthcare Diagnostics, reported 2014-02-05, distributed nationwide. Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid
| Recall number | Z-0868-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2013-08-27 |
| Classified | 2014-01-30 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2017-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CH, CN, CO, CR, CY, CZ, DE, DO, DZ, EC, EE, EG, ES, FR, GB, GR, GT, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, KR, KW, LB, LK, LT, LV, MT, MX, MY, NL, NO, NP, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SG, SK, SV, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 4,695 kits |
| Lot numbers | 737, 738, 739, 740, 741, 742, 743 |
| Model numbers | L2KF32, L2KF36 |
Product
T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK. For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.
Reason for recall
Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.
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-0868-2014. 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.