Recall Z-3180-2011 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Catalog No. CS9100; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The Bond Aspirating Probe Cleaning System is intended for automated cleaning of aspirating probes on Bond-max and Bond-x instruments, using t
| 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 | 1 kit |
| 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.