Drug recall
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision…
FDA recall event 67065 · Class II · Lab Vision Corporation
Key facts
| Event ID | 67065 |
|---|---|
| Recall numbers | Z-0775-2014 |
| Recalling firm | Lab Vision Corporation |
| Product type | Devices |
| Products | Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues. |
| Initiation date | Dec 6, 2013 |
| Report date | Jan 22, 2014 |
| Termination date | Feb 25, 2014 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 3000719701 |
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: