Recall Z-1306-2014— Abbott Point Of Care Inc.

Name: FDA recall Z-1306-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-01

Class II · Terminated

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2014-01-01, terminated 2014-10-20. It names one FDA 510(k) clearance: K940918. Product: i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.. Reason: Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-01
Terminated: 2014-10-20
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 G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.

Reason for recall

Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.

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