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Method, Nephelometric, Immunoglobulins (G, A, M)

FDA product code CFN · Class 2 · Immunology

112
Registered devices
26
Adverse events
20
Recalls
61
510(k) clearances

Devices with this code

ADVIA® Chemistry IGA_2 Reagents — Siemens Healthcare Diagnostics Inc.Human IgG1 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800 — THE BINDING SITE GROUP LIMITEDOptilite® IgG3 Kit (x10) — THE BINDING SITE GROUP LIMITEDVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.N Antiserum to Human a1-acid Glycoprotein — Siemens Healthcare Diagnostics Products GmbHHuman IgG Liquid Reagent Kit for use on the SPAPLUS –Bulk Kit — THE BINDING SITE GROUP LIMITEDAtellica CH IgG_2 — Siemens Healthcare Diagnostics Inc.IMMAGE — Beckman Coulter, Inc.Optilite® IgG4 Kit (x10) — THE BINDING SITE GROUP LIMITEDN Latex IgM — Siemens Healthcare Diagnostics Products GmbHN Antiserum to Human Antithrombin III — Siemens Healthcare Diagnostics Products GmbHIMMAGE — Beckman Coulter, Inc.ADVIA® Chemistry IGM_2 Reagents — Siemens Healthcare Diagnostics Inc.N Antiserum to Human Fibrinogen — Siemens Healthcare Diagnostics Products GmbHOptilite IgA CSF Kit — THE BINDING SITE GROUP LIMITEDOptilite IgG4 Kit — THE BINDING SITE GROUP LIMITEDHuman IgG1 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® series — THE BINDING SITE GROUP LIMITEDHuman IgG CSF Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDHuman IgG4 Subclass BNII Kit — THE BINDING SITE GROUP LIMITEDHuman IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit — THE BINDING SITE GROUP LIMITEDVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Human IgG4 Kit for SPAPLUS (U.S Only) — THE BINDING SITE GROUP LIMITEDADVIA® Chemistry IGG_2 Reagents — Siemens Healthcare Diagnostics Inc.Optilite IgG CSF Kit — THE BINDING SITE GROUP LIMITED

Recent recalls

DateFirmReason
2024-05-27Beckman Coulter Inc.LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as
2023-12-15Siemens Healthcare Diagnostics, Inc.Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
2023-07-12Beckman Coulter Inc.Lipemic interference failed to meet the performance specification listed within the IFU.
2022-08-30SIEMENS HEALTHCARE DIAGNOSTICS INCN Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
2022-08-30SIEMENS HEALTHCARE DIAGNOSTICS INCN Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
2019-07-29The Binding Site Group, Ltd.There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the s
2018-11-06The Binding Site Group, Ltd.Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values repo
2018-07-25The Binding Site Group, Ltd.After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control res
2016-12-23The Binding Site Group, Ltd.A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct
2015-01-15Siemens Healthcare Diagnostics, Inc.Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 a

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.