Recall Z-1065-2011 ยท NJT Immunohistochemistry Reagents And Kits
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.
| Date | Feb 9, 2011 (initiated Nov 16, 2010) |
| Status | Terminated |
| 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 cont |
| Quantity | 653 units |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.