Z-0717-2014Class II

Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd...

Name: Z-0717-2014 Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd...
Creator: Leica Biosystems Newcastle Ltd.
Published: 2013-07-31
License: https://open.fda.gov/license/

Leica Biosystems Newcastle Ltd. / initiated 2013-07-31 / Terminated / root cause: manufacturing process

FDA source

Leica Biosystems Newcastle Ltd. began a recall of Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle... on 2013-07-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0717-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2014-01-10
Terminated: 2017-08-14
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.
Product code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: *** 1 ) Catalog Number: DS9390; Lot Numbers: 22017, 22139, 22262, 22337, 22411, 22514, 22541; *** 2) Catalog Number: DS9477; Lot Number: 22250

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0717-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0717-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)