Z-2361-2015Class II

i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch...

Name: Z-2361-2015 i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch...
Creator: Abbott Point Of Care Inc.
Published: 2015-06-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-06-15 / Terminated

FDA source

Abbott Point Of Care Inc. began a recall of 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... on 2015-06-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2361-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-15
Posted: 2015-08-10
Terminated: 2016-02-19
Recalling firm: Abbott Medical
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.
Product code: GJS Test, Time, Prothrombin
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.
FDA root cause: Under Investigation by firm
Action: Abbott Point of Care sent a recall letter dated June 15, 2015 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the enclosed Business Reply Card (BRC). A Proof of Destruction From (FG-4533 in included with letter and is required to be returned to APOC as part of the credit process. Customers with questions were instructed to contact APOC Technical Support at 800-366-8020, Option 1 or their APOC representative.
Quantity in commerce: 423,168 cartridges
Distribution: Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.
Product codes and lots: All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2361-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2361-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-10

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)