Home › Device types › KLI
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
FDA product code KLI · Class 2 · Clinical Chemistry
44
Registered devices
24
Adverse events
12
Recalls
86
510(k) clearances
Devices with this code
ARCHITECT — ABBOTT IRELANDT4 High Sensitivity AccuBind ELISA Test System - 192 wells — MONOBIND, INC.Total Thyroxine (tT4) ELISA — DRG International IncCEDIA T4 Assay — Microgenics CorporationARCHITECT — ABBOTT IRELANDAccess Total T4 — Beckman Coulter, Inc.Dimension® Flex® reagent cartridge T4 — Siemens Healthcare Diagnostics Inc.T4 High Sensitivity AccuBind ELISA Test System - 96 wells — MONOBIND, INC.DRI Thyroxine (T4) — Microgenics CorporationARCHITECT — ABBOTT IRELANDIMMULITE® 2000 Systems TT4 Total T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDTotal Thyroxine (T4) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTotal T4 Thyroxine) — Roche Diagnostics GmbHAIA-PACK T4 SAMPLE DILUTING SOLUTION — TOSOH CORPORATIONARCHITECT — ABBOTT IRELANDIMMULITE® 2000 Systems TT4 Total T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDTotal Thyroxine (T4) ELISA — DRG International IncTotal Thyroxine ELISA (Total T4 ELISA) — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ARCHITECT — ABBOTT IRELANDAIA-PACK T4 CALIBRATOR SET — TOSOH CORPORATIONFree Thyroxine (fT4) ELISA — DRG International IncIMMULITE®/IMMULITE® 1000 Systems T4 Total T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDQMedix™ — Diagnostic Automation, Inc.DRI Thyroxine (T4) — Microgenics Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-16 | Beckman Coulter, Inc. | Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product s |
| 2024-02-08 | Beckman Coulter, Inc. | Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results. |
| 2021-10-18 | DRG International, Inc. | Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a |
| 2021-10-14 | BioCheck, Inc. | Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. |
| 2020-03-10 | Ortho Clinical Diagnostics | The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine |
| 2016-06-02 | ORTHO-CLINICAL DIAGNOSTICS | Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior t |
| 2014-02-20 | Ortho-Clinical Diagnostics | Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. |
| 2011-03-10 | Beckman Coulter Inc. | The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 a |
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