Reported Mar 2, 2016 · Terminated
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative…
Leica Microsystems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leica Microsystems, Inc. · 1700 Leider Ln · Buffalo Grove, IL · 60089-6622
Is this the product you have?
- This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
- Lot codes and dates
- Product Code/NamePA0552 (All Lots) Bond Ready-to-Use Primary Antibody PAX-5 (1EW)
- Detection KitDS9800 BondTM Polymer Refine Detection Kit
- Affected Detection Kit Lots
42314423884247442486424994255542570425794262742645426834278042802428234285243050
- Amount recalled
- 1700 units
Where it was sold
Why it was recalled
The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied after the primary marker incubation as specified in the Instructions for Use Following the Instructions for Use.
This product could cause temporary or reversible health problems — stop using it.
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