CD64 CyQ
IQ Products B.V. · Model IQP-568C · UDI-DI 08719327451069
Description
The CyQ conjugated monoclonal antibody CD64 (clone 22) binds to a CD64 epitope distinct from the ligand-binding site and from the clone 32.2 antibody to CD64 epitope. It shows especially high affinity binding to human mononuclear phagocytes and polymorphonuclear leukocytes exposed to IFN-y or G-CSF. Its binding is not blocked in the presence of human IgG or immune complexes. CD64 reacts with the Fc gamma receptor 1 (FcyR1), a glycoprotein with a molecular weight of 72 kDa.The antigen is a high-affinity receptor for IgG and is able to bind human IgG1 and IgG3. The antigen is expressed on macrophages, monocytes, and interferon y (IFN-y) and Granulocyte Colony Stimulating Factor (G-CSF) stimulated neutrophils.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-11-01 | Kreatech Biotechnology Bv | The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be |
| 2024-02-01 | Abbott Molecular, Inc. | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. |
| 2023-10-25 | Becton, Dickinson and Company, BD Biosciences | In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis |
| 2023-05-24 | Cytocell Ltd. | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| 2023-05-24 | Cytocell Ltd. | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| 2022-10-27 | Cytocell Ltd. | Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device |
| 2022-10-27 | Cytocell Ltd. | An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using t |
| 2022-03-25 | Becton, Dickinson and Company, BD Biosciences | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. |
| 2022-03-25 | Becton, Dickinson and Company, BD Biosciences | Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. |
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