i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
FDA device recall Z-0456-2011 · posted 2010-11-24 · Terminated
Recall details
- Recalling firm
- Abbott Point of Care Inc.
- Reason for recall
- The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.
- Action taken
- Abbott Point of Care issued Urgent Product Recall Notification letters dated March 2010 to all direct customers identifying the affected product and the actions to be taken. Customers were instructed to determine if they had cartirdges that had been stored above 25 degrees Celsius, and if so, contact Abbott for replacement or credit. Abbott Technical Support can be contacted at 800-366-8020 option 1 about this recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGL
- Quantity affected
- 34525 cartridges
- Distribution
- Worldwide Distribution: Throughout USA and Canada.
- Date initiated
- 2010-03-17
- Date posted
- 2010-11-24
- 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 SYSTEM (K973292) | I-Stat Corp. | 1997-10-20 |