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U.S. Department of Health and Human Services

Class 2 Device Recall Novocastra Liquid Mouse Monoclonal Antibody Glutathione STransferase pi

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  Class 2 Device Recall Novocastra Liquid Mouse Monoclonal Antibody Glutathione STransferase pi see related information
Date Initiated by Firm February 26, 2014
Date Posted June 02, 2014
Recall Status1 Terminated 3 on August 14, 2017
Recall Number Z-1698-2014
Recall Event ID 68065
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
Code Information Product Code: NCL-L-GSTpi-438; Lot Numbers and Expiration Dates: 6018777, Expires 2014-05; 6023260, Expires 2014-12; 6026297, Expires 2015-05; 6026980, Expires 2015-06
Recalling Firm/
Manufacturer		 Leica Microsystems, Inc.
1700 Leider Ln
Buffalo Grove IL 60089-6622
For Additional Information Contact
847-405-5413
Manufacturer Reason
for Recall		 Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Leica Biosystems sent a Medical Device Recall Notification letter dated February 26, 2014 to all direct accounts. The letter advised that clinicians may want to review results obtained from the affected products. The letter also included instructions for customers to: 1) appropriately destroy any unused or partially used NCL-L-GSTpi-438 (lots 6018777, 6023260,6026297, 6026980) reagent or confirm that they are not in stock; 2) complete and return the attached Medical Device Recall Notification Acknowledgement Form to 847-236-3747; and, 3) contact the local Leica representative immediately if replacement is required. Customers with questions or concerns about this recall can contact Leica via e-mail at LMGRA@leica-microsystems.com. For questions regarding this recall call 847-405-5413.
Quantity in Commerce 33 units
Distribution Nationwide Distribution including AZ, CA, FL, and NY.
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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