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

FDA device recall Z-1710-2014 · posted 2014-06-04 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

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.

Action taken

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 LMGRA@leica-microsystems.com.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

NJT

Quantity affected

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, R

Date initiated

2014-01-10

Date posted

2014-06-04

Date terminated

2017-09-05

Location

Buffalo Grove, IL