Device 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.
Z-0673-2020
Product summary
- Event
- Event 84301
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 558
- Official record key
device-enforcement:Z-0673-2020
Official wording
Reason: BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Code information: Lot: 65549
Distribution pattern: Nationwide and OUS to Canada.
Derived failure modes
-
Unknown
BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.