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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT PT/INR Cartridge

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 Class 2 Device Recall iSTAT PT/INR Cartridgesee related information
Date Initiated by FirmMay 05, 2010
Date PostedJuly 13, 2010
Recall Status1 Terminated 3 on September 22, 2011
Recall NumberZ-1996-2010
Recall Event ID 55895
510(K)NumberK020355 
Product Classification Test, time, prothrombin - Product Code GJS
Producti-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
Code Information 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.
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information ContactMr. Peter J. Scott
609-454-9000
Manufacturer 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 Determined
Cause 2		Other
ActionUrgent 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 Commerce44976 in US, 3648 in rest of world.
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GJS
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