Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage:

FDA device recall Z-1315-2015 · posted 2015-03-24 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

The staining intensity decreases over the shelf life.

Action taken

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 LMGRA@leica-microsystems.com.

Root cause

Labeling design

Status

Terminated

Product code

NJT

Quantity 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

Date initiated

2014-12-16

Date posted

2015-03-24

Date terminated

2017-09-05

Location

Buffalo Grove, IL