Home › Device types › CDP
Radioimmunoassay, Total Triiodothyronine
FDA product code CDP · Class 2 · Clinical Chemistry
123
Registered devices
1,979
Adverse events
20
Recalls
144
510(k) clearances
Devices with this code
Alinity — ABBOTT IRELANDTotal T3 125I RIA Kit — MP BIOMEDICALS, LLCAIA-PACK TT3 SAMPLE DILUTING SOLUTION — TOSOH CORPORATIONFree T3 125I RIA Kit — MP BIOMEDICALS, LLCQmedix — Diagnostic Automation, Inc.VITROS — ORTHO CLINICAL DIAGNOSTICST3 Total ELISA — DRG International IncAtellica IM FT3 — Siemens Healthcare Diagnostics Inc.Total T3 125I RIA Kit — MP BIOMEDICALS, LLCT3 SBS AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.ARCHITECT — ABBOTT IRELANDIMMULITE® 2000 Systems T3 Total T3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAlinity — ABBOTT IRELANDT3 AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Elecsys FT3 III — Roche Diagnostics GmbHIMMULITE®/IMMULITE® 1000 Systems T3 T3 Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDimension® EXL™ LOCI® Module Flex® reagent cartridge FT3 — Siemens Healthcare Diagnostics Inc.Access Total T3 — Beckman Coulter, Inc.IMMULITE®/IMMULITE® 1000 Systems T3 Total T3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDT3 free — DRG Instruments Gesellschaft mit beschränkter HaftungT3 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.ADVIA Centaur® FT3 — Siemens Healthcare Diagnostics Inc.Elecsys FT3 III — Roche Diagnostics GmbHT3 SBS AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.
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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