ARCHITECT Total T3 Reagent Kit — Class II medical device recall Z-0474-2015
Terminated recall by Abbott Ireland Diagnostics Division, reported 2014-12-03, distributed nationwide. 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower R
| Recall number | Z-0474-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Ireland Diagnostics Division, Co. Longford, N/A, Ireland |
| Recall initiated | 2014-09-11 |
| Classified | 2014-11-26 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BB, BD, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DE, EC, EG, ES, GB, GR, GT, HK, HN, HR, ID, IE, IL, IN, IR, IT, JM, JP, KE, KR, KW, KY, LB, LK, LV, MX, MY, NL, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SG, SK, SV, TH, TR, TT, TW, UA, VE, VN |
| Quantity | 7,415 kits |
| Lot numbers | 38901UI00, 38901UI01 |
| Expiration dates | 2015-01-29 |
Product
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
Reason for recall
17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.
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-0474-2015. 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.