Recall Z-2133-2012— Abbott Point Of Care Inc.

Name: FDA recall Z-2133-2012
Creator: U.S. Food and Drug Administration
Published: 2011-01-01

Class II · Terminated

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2011-01-01, terminated 2013-05-22. It names one FDA 510(k) clearance: K940918. 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.. 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..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-01-01
Terminated: 2013-05-22
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K940918 — I-STAT 200 PORTABLE CLINICAL ANALYZERI-Stat Corp.·cleared 1994-05-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.