i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
FDA Recall Z-0456-2011 · Posted 2010-11-24
Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeCGL
Date Initiated2010-03-17
Date Terminated2011-09-22
Product Quantity34525 cartridges
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution: Throughout USA and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.