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.
Recall
- Recall Number
- Z-1876-2016
- Event Number
- 73802
- Firm
- Leica Microsystems, Inc.
- FEI Number
- 3000210133
- Product Code
- NJT
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 5, 2016
- Terminated
- November 30, 2017
- Address
- 1700 Leider Ln, Buffalo Grove, IL, 60089-6622
Description
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.
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.
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 undertaken. The firm also request that the notification is passed to all those within their organization who need to be aware of this issue. The firm requests consignees to return the completed acknowledgement form to [email protected] to receive credit for affected lots that have been destroyed by the consignees laboratory.
Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
270 units