Recall Z-1710-2014 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
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.
| Date | Jun 4, 2014 (initiated Jan 10, 2014) |
| Status | Terminated |
| 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. |
| 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 LMGRA@leica-microsys |
| Quantity | 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 Kin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.