Reported Jun 17, 2020 · Completed
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic…
Ventana Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ventana Medical Systems Inc · 1910 E Innovation Park Dr · Oro Valley, AZ · 85755-1962
Is this the product you have?
- Model Number06917259001
- UDI04015630976010 -
- Product UsageThe System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
- Lot codes and dates
- All lots
- Amount recalled
- 461
Where it was sold
Why it was recalled
The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.
This product could cause temporary or reversible health problems — stop using it.
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