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BOND™
LEICA BIOSYSTEMS NEWCASTLE LTD · Model PA0151-U · UDI-DI 05055331334497
MYA
Prescription
1
510(k) clearances
19
Adverse events
3
Recalls
10
Facilities
Description
Estrogen Receptor Clone 6F11 Ready-To-Use Primary Antibody For BOND monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human estrogen receptor (ER) 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. |
| 2011-05-16 | Ventana Medical Systems Inc | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Unive |
| 2011-05-16 | Ventana Medical Systems Inc | The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Unive |
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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.