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.
This recall has been terminated (originally issued June 4, 2014).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- January 10, 2014
- Posted
- June 4, 2014
- Terminated
- September 5, 2017
- Recall Number
- Z-1710-2014
- Quantity
- 145 units
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03
Root Cause
Incorrect or no expiration date
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.