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U.S. Department of Health and Human Services

Class 2 Device Recall LEICA BIOSYSTEMS NEWCASTLE LTD

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  Class 2 Device Recall LEICA BIOSYSTEMS NEWCASTLE LTD see related information
Date Initiated by Firm April 05, 2016
Create Date June 01, 2016
Recall Status1 Terminated 3 on November 30, 2017
Recall Number Z-1876-2016
Recall Event ID 73802
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product 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.
Code Information 1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact Katya Magee
800-225-8867
Manufacturer 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.
FDA Determined
Cause 2		 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 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 LMGRA@Leica-Microsystems.com to receive credit for affected lots that have been destroyed by the consignees laboratory.
Quantity in Commerce 270 units
Distribution Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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