i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
FDA Recall Z-1996-2010 · Posted 2010-07-13
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Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeGJS
Date Initiated2010-05-05
Date Terminated2011-09-22
Product Quantity44976 in US, 3648 in rest of world.
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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