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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

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.
Recall Number Z-2133-2012
Classification Class II
Code Info List number 03P76-25 Lot number S10246A
Product Distributed Qty 52,750 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.

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 Letter
Distribution Pattern USA ( nationwide )