i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
This recall has been terminated (originally issued November 24, 2010).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- March 17, 2010
- Posted
- November 24, 2010
- Terminated
- September 22, 2011
- Recall Number
- Z-0456-2011
- Quantity
- 34525 cartridges
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: Throughout USA and Canada.
Lot / Code Info
Lot numbers A09279A and A09280A, Exp March 2010
Root Cause
Other
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.