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    Active INTACT PTH, Part Number: DSL-8000 The DSL-80000 ACTIVE Intact PTH IRMA Kit provides materials for the quantitative measurement of Intact PTH (I-PTH) in serum or plasma. The assay is intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEW·April 22, 2010

    Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEW·April 22, 2010

    Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEW·March 4, 2010

    ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JJX·February 12, 2014

    ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JIT·February 12, 2014

    ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CEW·August 16, 2013

    ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CEW·October 3, 2008

    ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JJX·April 9, 2019

    ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JIT·April 9, 2019

    LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON Analyzer family.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code CEW·November 23, 2020

    SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma and serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CEW·November 22, 2016

    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code CEW·October 26, 2016

    Elecsys PreciControl Varia 3

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JJY·April 10, 2017

    IMMULITE 2000 Intact PTH kit

    FDA Recall
    Terminated ·Diagnostic Products Corp·Product code CEW·February 23, 2004

    Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CEW·April 14, 2005

    Nichols IRMA Intact PTH Assay, catalog No. 40-2171

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CEW·March 25, 2005

    Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040

    FDA Recall
    Terminated ·Nichols Institute Diagnostics·Product code CEW·April 7, 2005

    Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CEW·April 19, 2007

    ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JIT·May 14, 2013

    ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JIT·May 14, 2013