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Terminated

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.

FDA Recall Z-2157-2012 · Posted 2012-08-08

Recalling FirmAbbott Point Of Care Inc.
Recall StatusTerminated
Product CodeGJS
Date Initiated2012-03-01
Date Terminated2013-02-08
Product Quantity2,950,296 cartridges US; 156,408 cartridges OUS

Reason for Recall

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

Firm Action

Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- (USA) nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020355I-STAT PROTHROMBIN TIME TESTI-Stat Corporation · 2002-05-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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