FDAFDA · Food and drugs·Recall number Z-1306-2014
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Published April 2, 2014 · Recall initiated: January 1, 2014
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
Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Point Of Care Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Canada.
- Lot
- List number 03P78-25 :Lot number N13183
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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