Recall Z-0808-2016 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining se
| Date | Feb 12, 2016 (initiated Nov 27, 2015) |
| Status | Terminated |
| Reason | The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining. |
| Root cause | Mixed-up of materials/components |
| Action | Leica Biosystems sent an Urgent Medical Device Recall Notice dated November 30, 2015, to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Please also properly destroy any unused or partially used affected lots of the reagent, and indicate by signing and returning the attached Medical Device Recall Acknowledgement Form that this action has bee |
| Quantity | 3745 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands, Romania Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Tu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.