Z-0673-2020 Class II Ongoing
FDA device recall Z-0673-2020 was initiated by Leica Microsystems, Inc. on November 18, 2019 and is designated Class II. Reason for recall: BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. The recall status is ongoing. Affected quantity: 558.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- November 18, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 558
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.
Distribution Pattern
Nationwide and OUS to Canada.
Code Information
Lot: 65549