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Method, Nephelometric, Immunoglobulins (G, A, M)
FDA product code CFN · Class 2 · Immunology
112
Registered devices
24
Adverse events
20
Recalls
61
510(k) clearances
Devices with this code
Immunoglobulin M — Roche Diagnostics GmbHDImension Vista® Immunoglobulin A Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHN Antiserum to Human Apolipoprotein A-I — Siemens Healthcare Diagnostics Products GmbHOptilite IgG Kit — THE BINDING SITE GROUP LIMITEDN Antiserum to Human Apolipoprotein B — Siemens Healthcare Diagnostics Products GmbHAU — Beckman Coulter, Inc.Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit — THE BINDING SITE GROUP LIMITEDHuman IgG4 Kit for SPAPLUS (U.S Only) — THE BINDING SITE GROUP LIMITEDN Antisera to Human IgG — Siemens Healthcare Diagnostics Products GmbHIMMAGE — Beckman Coulter, Inc.Human IgG2 Kit for SPAPLUS — THE BINDING SITE GROUP LIMITEDOptilite IgG2 Kit — THE BINDING SITE GROUP LIMITEDN Diluent — Siemens Healthcare Diagnostics Products GmbHHuman IgG2 Subclass BNII Kit — THE BINDING SITE GROUP LIMITEDVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit — THE BINDING SITE GROUP LIMITEDN Latex IgM — Siemens Healthcare Diagnostics Products GmbHHuman IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II — THE BINDING SITE GROUP LIMITEDHuman IgG2 SPA PLUS Bulk Kit — THE BINDING SITE GROUP LIMITEDHuman IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) — THE BINDING SITE GROUP LIMITEDN Antiserum to Human a1-acid Glycoprotein — Siemens Healthcare Diagnostics Products GmbHN Antiserum to Human Plasminogen — Siemens Healthcare Diagnostics Products GmbHHuman IgG Liquid Reagent Kit for use on the SPAPLUS — THE BINDING SITE GROUP LIMITEDHevylite IgA Lambda Kit for Siemens BNII — THE BINDING SITE GROUP LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-27 | Beckman 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 |
| 2023-12-15 | Siemens 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. |
| 2023-07-12 | Beckman Coulter Inc. | Lipemic interference failed to meet the performance specification listed within the IFU. |
| 2022-08-30 | SIEMENS HEALTHCARE DIAGNOSTICS INC | N 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). |
| 2022-08-30 | SIEMENS HEALTHCARE DIAGNOSTICS INC | N 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). |
| 2019-07-29 | The 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 |
| 2018-11-06 | The 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 |
| 2018-07-25 | The 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 |
| 2016-12-23 | The 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 |
| 2015-01-15 | Siemens 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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