Recall Z-1876-2016 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
| Date | Apr 5, 2016 |
| Status | Terminated |
| Reason | Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent: Medical Device Recall Notification dated 4/5/2016 was sent to consignees with the affected lots of CDX2 and RCC marker. The customers were notified of the problems as well as the following actions to be taken by the consignees: Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Appropriately destroy any unused or partially used affected lots of the reagent Complete the attached Recall Notification Acknowledgement Form that this action has been undert |
| Quantity | 270 units |
| Distribution | Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.