Home › Device types › CEC
Radioimmunoassay, Free Thyroxine
FDA product code CEC · Class 2 · Clinical Chemistry
57
Registered devices
1,922
Adverse events
12
Recalls
92
510(k) clearances
Devices with this code
FastPack® IP Free T4 Kit (30) — QUALIGEN INC.ARCHITECT — ABBOTT IRELANDARCHITECT — ABBOTT IRELANDIMMULITE® 2000 Systems FT4 Free T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDARCHITECT — ABBOTT IRELANDAtellica IM FT4 — Siemens Healthcare Diagnostics Inc.Dimension® EXL™ LOCI® Module Flex® reagent cartridge FT4L — Siemens Healthcare Diagnostics Inc.Atellica IM T4 — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT IRELANDADVIA Centaur® FT4 MCM — Siemens Healthcare Diagnostics Inc.Atellica IM FT4 MCM — Siemens Healthcare Diagnostics Inc.Free T4 AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.MAGLUMI 2000 FT4 — Shenzhen New Industries Biomedical Engineering Co., Ltd.Elecsys FT4 II Assay — Roche Diagnostics GmbHFree T4 MAb 125I RIA Kit — MP BIOMEDICALS, LLCVITROS — ORTHO CLINICAL DIAGNOSTICSElecsys FT4 II — Roche Diagnostics GmbHAIA-PACK FT4 Calibrator Set — TOSOH CORPORATIONFree T4 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Monobind AccuBind Free T4 ELISA Kit - 480 Wells — MONOBIND, INC.AccuDiag ™ — Diagnostic Automation, Inc.ADVIA Centaur® FT4 — Siemens Healthcare Diagnostics Inc.Free Thyroxine (fT4) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIMMULITE® 2000 Systems FT4 Free T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-30 | Beckman Coulter Inc. | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays |
| 2018-11-21 | Abbott Ireland Diagnostics Division | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Append |
| 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 |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimensio |
| 2017-05-09 | Beckman Coulter Inc. | The Access immunoassays are susceptible to biotin interference. |
| 2013-11-08 | Qualigen Inc | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| 2010-11-11 | Beckman Coulter Inc. | The recall was initiated because the stability claim for Access Free T4 calibrator lot 014769 is not met. The affected T4 calibrator lot can produce quality con |
| 2010-04-12 | Siemens Healthcare Diagnostics, Inc. | Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaki |
| 2010-03-24 | Beckman Coulter Inc. | The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs la |
| 2003-05-30 | Abbott Laboratories HPD/ADD | The Free T4 Controls, may yield control values that are high and outside of the package insert ranges. |
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