FDA Medical Device Recalls (openFDA)
Leica Microsystems, Inc.: 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.
- Recall number
- Z-1065-2011
- 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.
- Status
- Terminated
- Initiated
- 2010-11-16
- Posted
- 2011-02-09
- Terminated
- 2011-10-17
- Reason
- 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.
- 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
- 653 units
- Distribution
- Worldwide Distribution -- USA and Canada.
- Lot, serial or model codes
- Lot numbers 11279, 11297, 11315, 111604, 11693, and 11967.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3000210133
- Firm city
- Bannockburn
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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