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 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.

Recall number

Z-0717-2014

Recalling firm

Leica Biosystems Newcastle Ltd.

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.

Status

Terminated

Initiated

2013-07-31

Posted

2014-01-10

Terminated

2017-08-14

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 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

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.

Lot, serial or model codes

*** 1 ) Catalog Number: DS9390;  Lot Numbers: 22017, 22139, 22262, 22337, 22411, 22514, 22541;  *** 2) Catalog Number: DS9477;  Lot Number: 22250

510(k) numbers

not on file

PMA numbers

not on file

Product code

NJT

Firm FEI

3004859032

Firm city

Newcastle Upon Tyne

Firm state

not on file

Firm country

United Kingdom

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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