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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62371
Product Type Devices
Status Completed
Recalling Firm Abbott Point Of Care Inc.
City Princeton
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-01-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA ( nationwide )

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. List number 03P76-25 Lot number S10246A Class II 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. 52,750 cartridges Z-2133-2012