FDA-Device2016-02-24Class II
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
Leica Microsystems, Inc.
Hazard
The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.
Sold states
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands, Romania Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and UK.
Affected count
3745
Manufactured in
1700 Leider Ln, Buffalo Grove, IL, United States
Products
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2016Don't want to check this manually?
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