Z-0451-2014Class II

Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin...

Name: Z-0451-2014 Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin...
Creator: Abbott Point Of Care Inc.
Published: 2013-10-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-10-28 / Terminated / root cause: manufacturing process

FDA source

Abbott Point Of Care Inc. began a recall of Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients... on 2013-10-28. FDA classified it as Class II and gives the reason as "Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR". 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-0451-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-28
Posted: 2013-12-04
Terminated: 2014-05-29
Recalling firm: Abbott Medical
Product: Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Product code: GJS Test, Time, Prothrombin
Reason for recall: Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Abbott Point of Care Inc. (APOC) issued an Urgent Recall Notice on October 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from PT/INR lots in this letter. All unused cartridges would be credited and are to be returned as instructed on the enclosed Business Reply Card. If customers provided cartridges from the lot number listed above to another institution they were instructed to provide a copy of this letter to them. Customers with questions were instructerd to contact Abbott Point of Care Technical at 1-800-366-8020, Option 1. For questions regarding this recall call 800-366-8020.
Quantity in commerce: 794,928 units US; 119,472 units OUS
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,
Product codes and lots: K020355 List number 04J50-01, 04J50-02; 03P89-24 Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0451-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0451-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)