PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 1, 2015 Initiated: December 16, 2014 #Z-1315-2015

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.

Details

Recalling Firm
Leica Microsystems, Inc.
Units Affected
309 units
Distribution
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.
Location
Buffalo Grove, IL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Leica Microsystems, Inc.. Units affected: 309 units.
Why was this product recalled? ▼
The staining intensity decreases over the shelf life.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 1, 2015. Severity: Moderate. Recall number: Z-1315-2015.

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