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BOND-PRIME

LEICA BIOSYSTEMS NEWCASTLE LTD · Model DS9397 · UDI-DI 05055331337504

NJT Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

For in vitro diagnostic use. ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the visualization of tissue-bound mouse IgG and rabbit primary antibodies. It is intended for target visualization by immunohistochemistry (IHC) in sections of formalin fixed, paraffin-embedded tissue using the automated BOND-PRIME system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. ChromoPlex 1 Dual Detection for BOND-PRIME is intended to be used with other devices for visualization of staining and as such, qualitative or semi-quantitative diagnostic function including specific disease indication and intended use population is described within the associated device labelling as required for that device.

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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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.