Recall Z-0341-2016— Leica Microsystems, Inc.

Name: FDA recall Z-0341-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

Class II · Terminated

Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2015-09-03, terminated 2017-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.. Reason: These Lot numbers are not stable up to the expiry date on the product labeling..

Recalling firm: Leica Microsystems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Terminated: 2017-11-30
Firm location: Buffalo Grove, IL, United States

Product description

Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.

Reason for recall

These Lot numbers are not stable up to the expiry date on the product labeling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.