Recall Z-0521-2013 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon
| Date | Dec 13, 2012 (initiated Nov 14, 2012) |
| Status | Terminated |
| Reason | RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity. |
| Root cause | Nonconforming Material/Component |
| Action | Leica Microsystems, Inc. sent a Product Recall Notification letter dated November 14, 2012, via first class mail on the same date, to all affected customers. The letter identified the product ,the problem, and the actions to be taken by the customers. Customers were instructed to discontinue use of the product and to return any unused/part used reagents to the Richmond, IL, location for replacement. The accounts were asked to complete the attached Acknowledgement Form, acknowledging receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back |
| Quantity | 322 vials |
| Distribution | Worldwide Distribution -- USA including Arkansas, California, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Rhode Island, Tennessee, Texas and Wisconsin, and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.