Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.
Recall
- Recall Number
- Z-1315-2015
- Event Number
- 70090
- Firm
- Leica Microsystems, Inc.
- FEI Number
- 3000210133
- Product Code
- NJT
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- December 16, 2014
- Posted
- March 24, 2015
- Terminated
- September 5, 2017
- Address
- 1700 Leider Ln, Buffalo Grove, IL, 60089-6622
Description
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.
The staining intensity decreases over the shelf life.
Leica sent an Urgent Medical Device Recall Notification letters dated December 16, 2014 to all customers of record. The letters included instructions for customers to: 1) destory any usused and partially used recalled materials or confirm that the materials are no longer in stock; 2) complete and return the attached Field Safety Correction Notice Acknowledgement Form; 3) contact your local Leica representative immediately if a replacement is required; and, 4) pass this notice primarily to the end users where the product has been sold and to all those within your organisation who need to be aware of this manufacturing issue. Customers with questions can contact Leica Microsystems via e-mail at [email protected].
Worldwide Distribution - US Nationwide in the states of CA, CT, FL, IA, ID, IL, MT, NC, NY, TX, WA and in the countries of: Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Denmark, El Salvador, France, Germany, Hungary, India, Italy, Japan, Netherlands, Nigeria, Portugal, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom.
309 units