FDA Recall 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.

Recall: Z-2133-2012 · Initiated January 1, 2011

Recall

Recall Number
Z-2133-2012
Event Number
62371
Firm
Abbott Point Of Care Inc.
FEI Number
2245578
Product Code
CHL
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
January 1, 2011
Posted
August 2, 2012
Terminated
May 22, 2013
Address
400 College Rd E, Princeton, NJ, 08540-6607

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

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.

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.

Distribution

USA ( nationwide )

Quantity

52,750 cartridges