Z-1065-2011

Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No...

Name: Z-1065-2011 Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No...
Creator: Leica Microsystems, Inc.
Published: 2010-11-16
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2010-11-16 / Terminated

FDA source

Leica Microsystems, Inc. began a recall of Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800; Leica Biosystems Newcastle Ltd., Balliol... on 2010-11-16. The reason FDA records is "Users of the Bond Polymer Refine Detection System, DS9800, may experience instances of "weak staining" due to the DAB Part B component, which may give a false negative result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1065-2011
Status: Terminated
Initiated: 2010-11-16
Posted: 2011-02-09
Terminated: 2011-10-17
Recalling firm: Leica Microsystems, Inc.
Product: Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. Intended for immunohistochemistry on paraffin-embedded tissue sections.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Users of the Bond Polymer Refine Detection System, DS9800, may experience instances of "weak staining" due to the DAB Part B component, which may give a false negative result.
FDA root cause: Other
Action: Leica Microsystems sent Medical Device Field Correction letters dated 11/16/10 to the affected users of the Bond Polymer Refine Detection System, DS9800 via first class mail on the same date, informing them that they may experience instances of "weak staining" due to the DAB Part B component in the affected lots, which may give a false negative result. The users were requested to test their DS9800 System prior to use to rule out that the DAB Part B components have been affected, using the enclosed testing protocol. If their system is affected, the users were instructed not to use it and contact Leica Technical Assistance Center for a replacement. The accounts were asked to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.
Quantity in commerce: 653 units
Distribution: Worldwide Distribution -- USA and Canada.
Product codes and lots: Lot numbers 11279, 11297, 11315, 111604, 11693, and 11967.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)