FDAFDA · Food and drugs·Recall number Z-0673-2020
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.
Published December 18, 2019 · Recall initiated: November 18, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Leica Microsystems, Inc.
- Distributor
- Nationwide and OUS to Canada.
- Lot
- Lot: 65549
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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