Recall Z-0808-2016— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2015-11-27, terminated 2017-01-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.. 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..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-27
- Terminated
- 2017-01-05
- Firm location
- Buffalo Grove, IL, United States
Product description
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 sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
Reason for recall
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.
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