Z-1996-2010

i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ

Name: Z-1996-2010 i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
Creator: Abbott Point of Care Inc.
Published: 2010-05-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-05-05 / Terminated

FDA source

Abbott Point of Care Inc. began a recall of i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ on 2010-05-05. The reason FDA records is "A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1996-2010
Status: Terminated
Initiated: 2010-05-05
Posted: 2010-07-13
Terminated: 2011-09-22
Recalling firm: Abbott Medical
Product: i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
Product code: GJS Test, Time, Prothrombin
Reason for recall: A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received.
FDA root cause: Other
Action: Urgent recall notifications were sent on May 13 2010. Customers were instructed to discontinue use and to return the identified lots. Additional questions are directed to Abbott Point of Care Technical Support at 800-3668020, Option 1 or your Abbott Point of Care representative.
Quantity in commerce: 44976 in US, 3648 in rest of world.
Distribution: Worldwide distribution: Argentina, Hong Kong, China, Finland, Greece, India, Portugal, Russian Federation, Saudi Arabia, United Arab Emirates, Italy, Spain, Australia, Germany, UK, Sweden, The Netherlands, France, Canada.
Product codes and lots: Catalog numbers: 04J50-01, 04J50-02. Lot numbers: N09315, exp 4/28/2010; N09323, exp 5/14/2010; N09323A, exp 5/14/2010; N09346A, exp 5/28/2010; S09347, exp 5/28/2010; S09354, exp 6/14/2010; T10009, exp 6/28/2010; T10011, exp 6/28/2010.

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)