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BOND
LEICA BIOSYSTEMS NEWCASTLE LTD · Model DS9494 · UDI-DI 05055331332820
NJT
Prescription
0
510(k) clearances
52
Adverse events (1 deaths)
92
Recalls
45
Facilities
Description
BOND ChromoPlex II Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP) and polymeric alkaline phosphatase (AP) antibody conjugate system for the visualization of tissue-bound mouse IgG, mouse IgM and rabbit primary antibodies. It is intended for target visualization by immunohistochemistry (IHC) or RNA chromogenic in situ hybridization (RNA CISH) in sections of formalin fixed, paraffin-embedded tissue using the automated BOND-MAX or BOND-III systems.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2025-08-11 | Agilent Technologies Denmark ApS | Their is the potential for weak staining which may result in false negative CD20 identification. |
| 2024-06-27 | Ventana Medical Systems, Inc. | Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. |
| 2021-07-30 | Leica Microsystems, Inc. | Product may not perform as specified in IFU. |
| 2021-07-15 | Cell Marque Corporation | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely t |
| 2019-11-18 | Leica Microsystems, Inc. | BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. |
| 2019-10-10 | Biocare Medical, LLC | Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining |
| 2018-08-02 | Ventana Medical Systems Inc | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
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