Z-2157-2012Class II

I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for...

Name: Z-2157-2012 I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for...
Creator: Abbott Point Of Care Inc.
Published: 2012-03-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-03-01 / Terminated / root cause: manufacturing process

FDA source

Abbott Point Of Care Inc. began a recall of 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... on 2012-03-01. FDA classified it as Class II and gives the reason as "The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2157-2012
Classification: Class II
Status: Terminated
Initiated: 2012-03-01
Posted: 2012-08-08
Terminated: 2013-02-08
Recalling firm: Abbott Medical
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.
Product code: GJS Test, Time, Prothrombin
Reason for recall: The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 2,950,296 cartridges US; 156,408 cartridges OUS
Distribution: Worldwide Distribution -- (USA) nationwide
Product codes and lots: List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2157-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2157-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08

Product code GJS

K020355Class III-Stat Prothrombin Time TestI-Stat Corporation / cleared 2002-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)