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BOND™

LEICA BIOSYSTEMS NEWCASTLE LTD · Model PA0312-U · UDI-DI 05055331334855

MXZ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Progesterone Receptor Clone 16 [PR(16)] Ready-to-Use Primary Antibody For BOND monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

Recalls

Date	Firm	Reason
2018-08-02	Ventana Medical Systems Inc	Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
2004-04-06	Zymed Laboratories Inc.	Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.
2004-04-06	Zymed Laboratories Inc.	Mouse anti-TTF-1 had become contaminated by immunoglobulins from mouse serum that was co-eluted during purification leading to false readings.

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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.