Recall Z-3181-2011 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The CDX2 (AMT28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CDX2 protein
| Date | Sep 9, 2011 (initiated Jul 26, 2011) |
| Status | Terminated |
| Reason | There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers. |
| Root cause | Employee error |
| Action | Leica Microsystems, Inc. notified all affected customers by telephone on July 26, 2011. The product, problem, and actions to be taken by the customers were discussed. Customers were instructed to discontinue use of the product and to return the product. All affected product has been returned to the firm. |
| Quantity | 3 units |
| Distribution | Nationwide Distribution-in the states of Indiana and Kentucky. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.