Recall Z-0456-2011 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
Abbott Point of Care Inc.
i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
| Date | Nov 24, 2010 (initiated Mar 17, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 34525 cartridges |
| Distribution | Worldwide Distribution: Throughout USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973292 | I-STAT SYSTEM I-Stat Corp., Oct 20, 1997 |