FDAFDA · Food and drugs·Recall number Z-2154-2012
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Published August 15, 2012 · Recall initiated: July 2, 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
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Greiner Bio-One North America, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Lot #B041206
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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