i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
This recall has been terminated (originally issued July 13, 2010).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- May 5, 2010
- Posted
- July 13, 2010
- Terminated
- September 22, 2011
- Recall Number
- Z-1996-2010
- Quantity
- 44976 in US, 3648 in rest of world.
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.