Device product
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.
Z-2133-2012
Product summary
- Event
- Event 62371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52,750 cartridges
- Official record key
device-enforcement:Z-2133-2012
Official wording
Reason: 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.
Code information: List number 03P76-25 Lot number S10246A
Distribution pattern: USA ( nationwide )
Derived failure modes
-
Unknown
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.