FDA Recall Terminated

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.

Recall: Z-1710-2014 · Initiated January 10, 2014

Recall

Recall Number
Z-1710-2014
Event Number
68090
Firm
Leica Microsystems, Inc.
FEI Number
3000210133
Product Code
NJT
Status
Terminated
Root Cause
Incorrect or no expiration date
Initiated
January 10, 2014
Posted
June 4, 2014
Terminated
September 5, 2017
Address
1700 Leider Ln, Buffalo Grove, IL, 60089-6622

Description

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.

Reason

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

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].

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

Quantity

145 units