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Open, Classified

BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.

FDA Recall Z-0673-2020 · Posted None

Recalling FirmLeica Microsystems, Inc.
Recall StatusOpen, Classified
Product CodeNJT
Date Initiated2019-11-18
Product Quantity558

Reason for Recall

BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.

Firm Action

Customers were notified with an Urgent Medical Device recall letter beginning 11/18/2019. The letter identified affected product, stated reason for recall, requested that product not be used and to dispose of any product on hand. A response form was asked to be completed and returned. Questions can be directed to Adam Blunier at 1-847-821-3462 or [email protected].

Root Cause

Environmental control

Distribution Pattern

Nationwide and OUS to Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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