i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ
FDA device recall Z-1996-2010 · posted 2010-07-13 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 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 Netherl
- Date initiated
- 2010-05-05
- Date posted
- 2010-07-13
- Date terminated
- 2011-09-22
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT PROTHROMBIN TIME TEST (K020355) | I-Stat Corporation | 2002-05-14 |