Recall Z-2157-2012— Abbott Point Of Care Inc.

Name: FDA recall Z-2157-2012
Creator: U.S. Food and Drug Administration
Published: 2012-03-01

Class II · Terminated

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2012-03-01, terminated 2013-02-08. It names one FDA 510(k) clearance: K020355. Product: I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.. Reason: The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-03-01
Terminated: 2013-02-08
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K020355 — I-STAT PROTHROMBIN TIME TESTI-Stat Corporation·cleared 2002-05-14

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 PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.

Reason for recall

The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.

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