Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit; Catalog No. DS9800; Leica Bi

FDA device recall Z-1065-2011 · posted 2011-02-09 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

NJT

Quantity affected

653 units

Distribution

Worldwide Distribution -- USA and Canada.

Date initiated

2010-11-16

Date posted

2011-02-09

Date terminated

2011-10-17

Location

Bannockburn, IL