Drug recall
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro…
FDA recall event 72802 · Class II · Leica Microsystems, Inc.
Key facts
| Event ID | 72802 |
|---|---|
| Recall numbers | Z-0808-2016 |
| Recalling firm | Leica Microsystems, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 27, 2015 |
| Report date | Feb 24, 2016 |
| Termination date | Jan 5, 2017 |
| City | Buffalo Grove |
| State | IL |
| Country | United States |
| FEI number | 3000210133 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: