Recall Z-1315-2015— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2014-12-16, terminated 2017-09-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The staining intensity decreases over the shelf life..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-16
- Terminated
- 2017-09-05
- Firm location
- Buffalo Grove, IL, United States
Product 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.
Reason for recall
The staining intensity decreases over the shelf life.
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