Recall Z-0717-2014 ยท NJT Immunohistochemistry Reagents And Kits
Leica Biosystems Newcastle Ltd.
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
| Date | Jan 10, 2014 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root 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 representatai |
| Quantity | 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.