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.
FDA Recall Z-2133-2012 · Posted 2012-08-02
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Recalling FirmAbbott Point Of Care Inc.
Recall StatusTerminated
Product CodeCHL
Date Initiated2011-01-01
Date Terminated2013-05-22
Product Quantity52,750 cartridges
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.
Firm Action
Abbott Point of Care, Inc sent a Urgent Recall Notice letter dated January 14, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to discontinue use of Cartridges from the identified lot. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card.
If you have any questions regarding this information please contact your Abbott Point of Care Technical Support at 800-366-8020 Option 1, or your Abbott Point of Care representative.
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA ( nationwide )
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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