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CD33-APC
Miltenyi Biotec B.V. & Co. KG · Model 170-081-024 · UDI-DI 04049934134357
0
510(k) clearances
74
Adverse events
43
Recalls
116
Facilities
Description
AC104.3E3 recognizes the human CD33 antigen, a 67 kDa glycoprotein belonging to the sialoadhesin superfamily. The CD33 antigen is highly expressed on human monocytes but weakly on granulocytes and some – but not all – myeloid dendritic cells. The CD33 antigen is also found on myeloid progenitor cells (CFU-GEMM, CFU GM, CFU-G, BFU-E) but is not expressed on lymphocytes, platelets, erythrocytes, or primitive hematopoietic stem cells.
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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Get your free API keyRead the docsData 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.