Class 2 Device Recall BOND Polymer Refine Red Detection

• Date Initiated by Firm: July 31, 2013
• Date Posted: January 10, 2014
• Recall Status: Terminated on August 14, 2017
• Recall Number: Z-0717-2014
• Recall Event ID: 66030
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: 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.
• Code Information: *** 1 ) Catalog Number: DS9390; Lot Numbers: 22017, 22139, 22262, 22337, 22411, 22514, 22541; *** 2) Catalog Number: DS9477; Lot Number: 22250
• Recalling Firm/ Manufacturer: Leica Biosystems Newcastle Ltd.; Balliol Business Park West,; Benton Lane; Newcastle Upon Tyne United Kingdom
• For Additional Information Contact: Ms. Katya Magee; 847-405-5413
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: Leica Biosystems sent an Urgent Field Safety Correction Notice dated July 31, 2013, to all affected customers. The notice requests that direct accounts either destroy any unused reagents or confirm that the product has been used and in no longer in stock. Direct accounts are requested to sign the notice and either fax or scan and e-mail it back to Leica Biosystems Newcastle Ltd. The notice further requests that direct accounts who further distributed the recalled products forward the notification to their customers. Customers with questions were instructed to contact their Leica representataive if a replacement is necessary, for any questions customers were instructed call 847-405-5413 or microsystems.com. For questions regarding this recall call 847-405-5413.
• Quantity in Commerce: 1) 2,304 units; 2) 37 units
• Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and WV); and Internationally to Chile, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Sweden, Switzerland, Poland, Romania, Singapore, South Korea, and the United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.