FDAFDA · Food and drugs·Recall number Z-0490-2013
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Published December 19, 2012 · Recall initiated: July 16, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Molecular Systems, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Device-associated diagnostic software
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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