ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or… — Class II medical device recall Z-0799-2019
Terminated recall by Abbott Ireland Diagnostics Division, reported 2019-02-13, distributed nationwide. Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagen
| Recall number | Z-0799-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Ireland Diagnostics Division, Co. Longford, Ireland |
| Recall initiated | 2018-10-12 |
| Classified | 2019-02-04 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2020-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AT, BD, BE, BG, BH, BS, CA, CH, CL, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, HN, HR, HU, ID, IE, IL, IQ, IR, IT, JM, JO, KE, KW, KY, LB, LK, LT, LU, LV, MA, MY, NG, NI, NL, NO, NP, OM, PA, PE, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TN, TR, TT, UA, VN, ZA |
| Quantity | 191,410 units |
Product
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
Reason for recall
Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms.
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-0799-2019. 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.