Z-0808-2016 Class II Terminated
FDA device recall Z-0808-2016 was initiated by Leica Microsystems, Inc. on Nov 27, 2015 and is designated Class II. 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… The recall status is terminated (terminated Jan 5, 2017). Affected quantity: 3745.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 24, 2016
- Initiation Date
- Nov 27, 2015
- Termination Date
- Jan 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3745
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.
Distribution Pattern
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, Turkey and UK.
Code Information
Product Code DS9390 with lot numbers 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512 and 42594.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0808-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026