Z-1710-2014Class II

Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM...

Name: Z-1710-2014 Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM...
Creator: Leica Microsystems, Inc.
Published: 2014-01-10
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2014-01-10 / Terminated / root cause: labeling and UDI

FDA source

Leica Microsystems, Inc. began a recall of Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro... on 2014-01-10. FDA classified it as Class II and gives the reason as "Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity". 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-1710-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-10
Posted: 2014-06-04
Terminated: 2017-09-05
Recalling firm: Leica Microsystems, Inc.
Product: Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Leica sent an Urgent Field Safety Correction Notice letter dated January 10, 2014 was sent ot all affected customers. The notice included instructions for recipients to: 1) destroy any unused or partially used NCL-L-CD15 (lots 6015073 and 6017936) reagent or confirm that the products are no longer in stock; 2) indicate on the attached Field Safety Correction Notice Acknowledgement Fom which action was taken; and, 3) contact the local Leica represetnative immediately if a replacement is required. Customers with any concerns about this notice can contact Leica via e-mail at [email protected].
Quantity in commerce: 145 units
Distribution: Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom
Product codes and lots: Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1710-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1710-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03

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)