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BOND™

LEICA BIOSYSTEMS NEWCASTLE LTD · Model PB0829 · UDI-DI 05055331303486

MVU Prescription

510(k) clearances

Adverse events

Recalls

116

Facilities

Description

HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA in formalin-fixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). This probe binds to the five high risk HPV subtypes, 16, 18, 31, 33 and 51.

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.	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
2022-10-27	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
2022-03-25	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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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.