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Radioimmunoassay, Parathyroid Hormone
FDA product code CEW · Class 2 · Clinical Chemistry
57
Registered devices
1,485
Adverse events
21
Recalls
86
510(k) clearances
Devices with this code
PTH Intact AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.IMMULITE® 2000 Systems PTH Intact PTH Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® iPTH — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHAtellica IM PTH — Siemens Healthcare Diagnostics Inc.PTH Whole & Intact AccuLite VAST CLIA Test System - 192 Wells — MONOBIND, INC.Elecsys PTH — Roche Diagnostics GmbHFuture Diagnostics — Future Diagnostics Solutions B.V.ADVIA Centaur® iPTH — Siemens Healthcare Diagnostics Inc.PTH (Parathyroid) Intact ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIMMULITE® 2000 Systems IPT Intact PTH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDADVIA Centaur® PTH — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems IPT Intact PTH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDimension® Heterogenous Immunoassay Module Flex® reagent cartridge TSH — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® PTH — Siemens Healthcare Diagnostics Inc.Elecsys PTH Immunoassay — Roche Diagnostics GmbHST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION — TOSOH CORPORATIONScantibodies Laboratory, Inc. — SCANTIBODIES LABORATORY, INC.ADVIA Centaur® PTH — Siemens Healthcare Diagnostics Inc.PTH (Parathyroid) Intact ELISA — DRG International IncAlinity — Abbott GmbHIMMULITE®/IMMULITE® 1000 Systems iPT Intact PTH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys PTH — Roche Diagnostics GmbHElecsys PTH — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-22 | Siemens Healthcare Diagnostics, Inc. | The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol |
| 2024-11-26 | Beckman Coulter, Inc. | Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could |
| 2024-11-08 | Beckman Coulter Inc. | The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolong |
| 2022-12-06 | Future Diagnostics Solutions B.V. | Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits. |
| 2022-11-17 | Ortho-Clinical Diagnostics, Inc. | Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results |
| 2020-11-23 | Diasorin Inc. | Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. |
| 2016-11-22 | Siemens Healthcare Diagnostics, Inc. | Siemens is conducting this recall for the IMMULITE 2000/IMMULITE 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Siemens has confirme |
| 2016-10-26 | Diagnostic Hybrids, Inc. | There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay. |
| 2016-10-05 | ORTHO-CLINICAL DIAGNOSTICS | The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the investigation th |
| 2013-08-16 | Siemens Healthcare Diagnostics, Inc | PTH Calibrator packaged with only high calibrator. |
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