FDA Device recall Z-0808-2016
Bond Polymer Refine Red Detection DS9390 kits
- FDA Device
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of Bond Polymer Refine Red Detection DS9390 kits by Leica Microsystems, citing 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 DS939….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0808-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-27 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Leica Microsystems |
| Distribution | US |
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.
Identifiers
| code_info | Product Code DS9390 with lot numbers 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512 and 42594. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0808-2016%22
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