Z-1315-2015Class II

Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining

Name: Z-1315-2015 Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining
Creator: Leica Microsystems, Inc.
Published: 2014-12-16
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2014-12-16 / Terminated / root cause: labeling and UDI

FDA source

Leica Microsystems, Inc. began a recall of Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the... on 2014-12-16. FDA classified it as Class II and gives the reason as "The staining intensity decreases over the shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1315-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-16
Posted: 2015-03-24
Terminated: 2017-09-05
Recalling firm: Leica Microsystems, Inc.
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.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: The staining intensity decreases over the shelf life.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1315-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1315-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-24

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)