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Radioimmunoassay, Total Triiodothyronine
FDA product code CDP · Class 2 · Clinical Chemistry
123
Registered devices
1,980
Adverse events
20
Recalls
144
510(k) clearances
Devices with this code
Total T3 125I RIA Kit — MP BIOMEDICALS, LLCARCHITECT — ABBOTT IRELANDARCHITECT — ABBOTT IRELANDTotal T3 125I RIA Kit — MP BIOMEDICALS, LLCST AIA-PACK FT3 — TOSOH CORPORATIONDimension Vista® Flex® reagent cartridge FT3 — Siemens Healthcare Diagnostics Inc.Free T3 125I RIA Kit — MP BIOMEDICALS, LLCAtellica IM T3/T4/VB12 ANC RGT — Siemens Healthcare Diagnostics Inc.Monobind AccuBind T3 ELISA Kit - 480 Wells — MONOBIND, INC.ADVIA Centaur® T3 — Siemens Healthcare Diagnostics Inc.IMMULITE®/IMMULITE® 1000 Systems TSH Third Generation TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDFree T3 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.IMMULITE®/IMMULITE® 1000 Systems T3 T3 Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® T3/T4/VB12 Anc — Siemens Healthcare Diagnostics Inc.Monobind AccuLite Free T3 CLIA Kit - 192 Wells — MONOBIND, INC.Total T3 125I RIA Kit — MP BIOMEDICALS, LLCADVIA Centaur® T3/T4/VB12 Ancillary Reagent — Siemens Healthcare Diagnostics Inc.Free Triiodothyronine (fT3) ELISA — DRG International IncADVIA Centaur® FT3 — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® T3 MCM — Siemens Healthcare Diagnostics Inc.Atellica IM FT3 — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® T3 — Siemens Healthcare Diagnostics Inc.Free T3 AccuBind ELISA Test System - 480 Wells — MONOBIND, INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-04-09 | QUIDELORTHO | T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause errone |
| 2023-03-15 | Beckman Coulter, Inc. | The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers n |
| 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 |
| 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 |
| 2018-11-30 | Tosoh Bioscience Inc | |
| 2018-10-12 | Abbott Ireland Diagnostics Division | 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 as |
| 2018-10-12 | Abbott Ireland Diagnostics Division | 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 as |
| 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 |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2017-07-28 | Siemens Healthcare Diagnostics, Inc | Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA C |
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