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CD185-APC

Miltenyi Biotec B.V. & Co. KG · Model 170-081-004 · UDI-DI 04049934134555

MVU
0
510(k) clearances
74
Adverse events
43
Recalls
116
Facilities

Description

REA103 recognizes human CD185, which is a 42 kDa G-protein-coupled chemokine receptor and is also known as CXCR5, monocyte-derived receptor 15 (MDR15), or Burkitt lymphoma receptor-1 (BLR1). BLR-1 was originally identified on cells of Burkitt lymphoma and B cells. B cell attracting chemokine 1 (BCA-1), also known as B-lymphocyte chemoattractant (BLC) or CXCL13, is the ligand of CD185. It is further expressed on central memory CD4 T cells, T follicular helper cells, and on a migratory population of skin-derived dendritic cells. Additional information: Clone REA103 displays negligible binding to Fc receptors.

Recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2024-11-01Kreatech Biotechnology BvThe 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
2024-02-01Abbott 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.
2023-10-25Becton, Dickinson and Company, BD BiosciencesIn 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
2023-05-24Cytocell Ltd.DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
2023-05-24Cytocell Ltd.DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
2022-10-27Cytocell 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
2022-10-27Cytocell 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
2022-03-25Becton, Dickinson and Company, BD BiosciencesAnti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
2022-03-25Becton, Dickinson and Company, BD BiosciencesAnti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

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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.