Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Leica BIOSYSTEMS Recalled by Leica Biosystems Newcastle Ltd. Due to The affected lots of the product may contain...
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 Biosystems Newcastle Ltd. directly.
Affected Products
Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. This detection system is for in vitro diagnostic use. 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. The clinical interpretation of any staining or its absence should be complemented by morphological studies. Proper controls should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The Bond Polymer Refine Red Detection must be used with laboratory best practice in the use of tissue controls. For assurance, laboratories should stain each patient sample in conjunction with positive, negative and other tissue specific controls as needed.
Quantity: 1) 2,304 units; 2) 37 units
Why Was This Recalled?
The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide.
Where Was This Sold?
This product was distributed to 40 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, WV, WI
About Leica Biosystems Newcastle Ltd.
Leica Biosystems Newcastle Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report