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CD42a-FITC

Miltenyi Biotec B.V. & Co. KG · Model 170-081-030 · UDI-DI 04049934134296

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

Description

Clone REA209 recognizes CD42a, a 22 KDa transmembrane glycoprotein, which is also known as glycoprotein IX (GPIX). CD42a is a single-pass type I membrane protein with leucine rich motif containing a series of tandem repeats of a 24-amino acid sequence flanked by conserved disulfide loops, in its ligand binding domains. Expression of CD42a is found on platelets and megakaryocytes. CD42a, together with GPIb receptor complex and platelet glycoprotein V forms a complex which serves as the receptor for von Willebrand factor (VWF). The interaction of the GPIb-IX-V complex to VWF initiates initial platelet adhesion to vascular subendothelium after vascular injury, platelet activation, thrombosis, and hemostasis. Other known ligands for GPIb–IX–V include α-thrombin, clotting factors XI/XIIa, and high-molecular weight kininogen. Additional information: Clone REA209 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.