Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
This reagent is for in vitro diagnostic use. Pax-5 (1EW) Recalled by Leica Microsystems, Inc. Due to The Bond" Polymer Refine Detection and Novolink" Polymer...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Leica Microsystems, Inc. directly.
Affected Products
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.
Quantity: 1700 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 36 states: AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IA, KY, LA, MD, MA, MI, MN, MO, MT, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI, DC
About Leica Microsystems, Inc.
Leica Microsystems, Inc. has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report