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Recall Observatory FDA recall evidence

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

January 01, 2011

Class II

Product summary

Firm
Abbott Point Of Care Inc.
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

    reason.no_named_rule · v1.0.0

    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.