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CD15-APC

Miltenyi Biotec B.V. & Co. KG · Model 170-081-049 · UDI-DI 04049934134104

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

Description

VIMC6 recognizes the human CD15 antigen which is expressed on human myelomonocytic cells. It is present on neutrophils, eosinophils, and some monocytes, masked on basophils but not on lymphocytes. The antigen is also expressed on Hodgkin/Reed-Sternberg cells. The CD15 antibody recognizes the carbohydrate structure 3-fucosyl-N-acetyl-lactosamine. This structure is also known as stage specific embryonic antigen 1 (SSEA-1) and a common surface marker for pluripotency on mouse ES and iPS cells. On human cells in contrast, SSEA-1 is expressed only on early differentiating cells. The CD15 antibody recognizes the SSEA-1 antigen in both species. For applications in ES and iPS research, the dilution recommended in the data sheet may need adjustment.

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.

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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.