FDAFDA · Food and drugs·Recall number Z-2133-2012
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
Published August 8, 2012 · Recall initiated: January 1, 2011
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
i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Point Of Care Inc.
- Distributor
- USA ( nationwide )
- Lot
- List number 03P76-25 Lot number S10246A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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