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Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BNII Analyser

THE BINDING SITE GROUP LIMITED · Model NK008.T · UDI-DI 05051700007764

CFN Prescription
10
510(k) clearances
26
Adverse events
20
Recalls
19
Facilities

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 normal
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 specified ranges. Thi
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 reporting outside the sp
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 results may be out of r
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 but contradicts the
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 and 44042.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.