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U.S. Department of Health and Human Services

Class 2 Device Recall NCLLCD15: Liquid Mouse Monoclonal Antibody CD15

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  Class 2 Device Recall NCLLCD15: Liquid Mouse Monoclonal Antibody CD15 see related information
Date Initiated by Firm January 10, 2014
Date Posted June 04, 2014
Recall Status1 Terminated 3 on September 05, 2017
Recall Number Z-1710-2014
Recall Event ID 68090
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
Code Information Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03
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		 Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Leica sent an Urgent Field Safety Correction Notice letter dated January 10, 2014 was sent ot all affected customers. The notice included instructions for recipients to: 1) destroy any unused or partially used NCL-L-CD15 (lots 6015073 and 6017936) reagent or confirm that the products are no longer in stock; 2) indicate on the attached Field Safety Correction Notice Acknowledgement Fom which action was taken; and, 3) contact the local Leica represetnative immediately if a replacement is required. Customers with any concerns about this notice can contact Leica via e-mail at LMGRA@leica-microsystems.com.
Quantity in Commerce 145 units
Distribution Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom
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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