Recall Z-2113-2014 ยท MVC System, Test, Her-2/Neu, Ihc
Biogenex Laboratories, Inc.
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
| Date | Jul 24, 2014 (initiated Jul 1, 2014) |
| Status | Terminated |
| Reason | Product was distributed without 510(k) approval. |
| Root cause | No Marketing Application |
| Action | Each customer contacted by phone - neither is in possession of the product. |
| Quantity | 4 kits |
| Distribution | Brazil and Ecuador. No US distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.