Recall Z-2361-2015— Abbott Point Of Care Inc.

Name: FDA recall Z-2361-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-15

Class II · Terminated

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2015-06-15, terminated 2016-02-19. It names one FDA 510(k) clearance: K020355. Product: i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.. Reason: Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-15
Terminated: 2016-02-19
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 Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.

Reason for recall

Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.

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