FDA Recall Terminated

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: Z-1065-2011 · Initiated November 16, 2010

Recall

Recall Number: Z-1065-2011
Event Number: 57333
Firm: Leica Microsystems, Inc.
FEI Number: 3000210133
Product Code: NJT
Status: Terminated
Root Cause: Other
Initiated: November 16, 2010
Posted: February 9, 2011
Terminated: October 17, 2011
Address: 2345 Waukegan Rd, Bannockburn, IL, 60015-1515

Description

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.

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.

Distribution

Worldwide Distribution -- USA and Canada.

Quantity

653 units