I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring pati
FDA device recall Z-2157-2012 · posted 2012-08-08 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- Reason for recall
- The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
- Action taken
- Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 2,950,296 cartridges US; 156,408 cartridges OUS
- Distribution
- Worldwide Distribution -- (USA) nationwide
- Date initiated
- 2012-03-01
- Date posted
- 2012-08-08
- Date terminated
- 2013-02-08
- 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 |