Leica Microsystems, Inc. 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 pathologis Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 pathologis
Brand
Leica Microsystems, Inc.
Lot Codes / Batch Numbers
Product Code: NCL-L-CD15, Lot Numbers and Expiration Dates: Lot 6022274, Expiry 2015-04, Lot 6024628, Expiry 2015-08, Lot 6030581, Expiry 2016-07
Products Sold
Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: Lot 6022274, Expiry 2015-04; Lot 6024628, Expiry 2015-08; Lot 6030581, Expiry 2016-07
Leica Microsystems, Inc. is recalling Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) stai due to The staining intensity decreases over the shelf life.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The staining intensity decreases over the shelf life.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 11, 2026