Recall Z-1315-2015 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within
| Date | Mar 24, 2015 (initiated Dec 16, 2014) |
| Status | Terminated |
| Reason | The staining intensity decreases over the shelf life. |
| Root cause | Labeling design |
| Action | Leica sent an Urgent Medical Device Recall Notification letters dated December 16, 2014 to all customers of record. The letters included instructions for customers to: 1) destory any usused and partially used recalled materials or confirm that the materials are no longer in stock; 2) complete and return the attached Field Safety Correction Notice Acknowledgement Form; 3) contact your local Leica representative immediately if a replacement is required; and, 4) pass this notice primarily to the end users where the product has been sold and to all those within your organisation who need to be awa |
| Quantity | 309 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, CT, FL, IA, ID, IL, MT, NC, NY, TX, WA and in the countries of: Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Denmark, El Salvador, France, Germany, Hungary, India, Italy, Japan, Netherlands, Nigeria, Portugal, Roman |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.