Recall Z-0673-2020— Leica Microsystems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2019-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-11-18
- Firm location
- Buffalo Grove, IL, United States
Product description
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.
Reason for recall
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
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