PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 8, 2012 Initiated: January 1, 2011 #Z-2133-2012

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Abbott Point Of Care Inc.
Units Affected
52,750 cartridges
Distribution
USA ( nationwide )
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Abbott Point Of Care Inc.. Units affected: 52,750 cartridges.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 8, 2012. Severity: Moderate. Recall number: Z-2133-2012.