FDA Device Intelligence
HomeMiltenyi Biotec B.V. & Co. KG › CD21-VioBlue

CD21-VioBlue

Miltenyi Biotec B.V. & Co. KG · Model 170-081-022 · UDI-DI 04049934134371

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

Description

HB5 recognizes CD21, a type I membrane glycoprotein. Expression of CD21 in humans is found on B cells, follicular dendritic cells, subsets of epithelial cells, and thymic T cells. The primary function attributed to CD21 has been to amplify the B cell receptor (BCR)-mediated signal transduction in response to antigen recognition. To enhance the BCR mediated activation, CD21 associates with CD19 and CD81 in a B cell–specific signal transduction complex, where interaction of BCR with CR2/CD19 amplifies the signals. In addition, CD21 serves as a receptor for split products of complement protein C3, the gp350/220 viral coat protein of the EBV and the immunoregulatory protein CD23.

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.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
2022-10-27Cytocell 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
2022-03-25Becton, 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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.