FDAFDA · Food and drugs·Recall number Z-1796-2013
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Published July 31, 2013 · Recall initiated: June 20, 2013
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
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Haemonetics Corporation
- Distributor
- US Nationwide
- Lot
- Per recall strategy.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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