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.
FDA Recall Z-1876-2016 · Posted None
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Recalling FirmLeica Microsystems, Inc.
Recall StatusTerminated
Product CodeNJT
Date Initiated2016-04-05
Date Terminated2017-11-30
Product Quantity270 units
Reason for Recall
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.
Firm 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 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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