Recall Z-2360-2018 ยท NJT Immunohistochemistry Reagents And Kits
Biocare Medical, LLC
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
| Date | Apr 24, 2018 |
| Status | Terminated |
| Reason | Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer. |
| Root cause | Material/Component Contamination |
| Action | On April 24, 2018 the recalling firm issued a notification letter to their customers with instructions to return a response form. |
| Quantity | 43 units |
| Distribution | CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.