Recall Z-2360-2018
Biocare Medical, LLC · initiated April 24, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot numbers 011818 and 022818
Reason for recall
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
FDA-determined cause: Material/Component Contamination
Action taken
On April 24, 2018 the recalling firm issued a notification letter to their customers with instructions to return a response form.
Details
- Recall number
- Z-2360-2018
- Initiated
- April 24, 2018
- Terminated
- July 14, 2020
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- Quantity
- 43 units
- Distribution
- CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
- Recalling firm
- Biocare Medical, LLC, Pacheco, CA