| Class 2 Device Recall NCLLCD15: Liquid Mouse Monoclonal Antibody CD15 |  |
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
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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
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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 |
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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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