Home › Device types › MVC
System, Test, Her-2/Neu, Ihc
FDA product code MVC · Class 3 · Unknown
7
Registered devices
20
Adverse events
8
Recalls
0
510(k) clearances
Devices with this code
BOND ORACLE HER2 IHC System — LEICA BIOSYSTEMS NEWCASTLE LTDHER2/neu [IHC042] — BIOCARE MEDICAL LLCHercepTest™ — AGILENT TECHNOLOGIES SINGAPORE PTE LTDHercepTest™ for the Dako Autostainer — AGILENT TECHNOLOGIES SINGAPORE PTE LTDPATHWAY HER-2 4 in 1 Control Slides — Ventana Medical Systems, Inc.PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody — Ventana Medical Systems, Inc.HercepTest™ for Automated Link Plarforms — AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Recent 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 cont |
| 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 cont |
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