FDAFDA · Food and drugs·Recall number Z-2179-2019
VITROS 5600 Integrated System, clinical chemistry analyzer
Published August 14, 2019 · Recall initiated: July 8, 2019
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
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Ortho Clinical Diagnostics
- Distributor
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
- Lot
- product code: 6802413 UDI: 10758750002740 Affected software : Version 3.3.2 or above
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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