FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0673-2020
·
Reported December 18, 2019
Enforcement
- Recall Number
- Z-0673-2020
- Event ID
- 84301
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Leica Microsystems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2019
- Initiation Date
- November 18, 2019
- Classification Date
- December 12, 2019
- Address
- 1700 Leider Ln, N/A, Buffalo Grove, IL, 60089-6622, United States
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
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Code Info
Lot: 65549
Distribution
Nationwide and OUS to Canada.
Quantity
558