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BOND ORACLE HER2 IHC System
LEICA BIOSYSTEMS NEWCASTLE LTD · Model TA9145 · UDI-DI 05055331301291
0
510(k) clearances
21
Adverse events
8
Recalls
7
Facilities
Description
Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue processed for histological evaluation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-07-01 | Biogenex Laboratories, Inc. | Product was distributed without 510(k) approval. |
| 2009-09-17 | Ventana Medical Systems Inc | Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody. |
| 2006-02-09 | Biogenex Laboratories | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |
| 2006-02-09 | Biogenex Laboratories | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |
| 2006-02-09 | Biogenex Laboratories | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |
| 2006-02-09 | Biogenex Laboratories | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. |
| 2005-09-29 | Dakocytomation California Inc | Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formula |
| 2005-09-29 | Dakocytomation California Inc | Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formula |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.