Device product
Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
Z-2360-2018
Product summary
- Event
- Event 80322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43 units
- Official record key
device-enforcement:Z-2360-2018
Official wording
Reason: Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
Code information: Lot numbers 011818 and 022818
Distribution pattern: CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
Derived failure modes
-
Unknown
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.