Z-0456-2011

i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc...

Name: Z-0456-2011 i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc...
Creator: Abbott Point of Care Inc.
Published: 2010-03-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-03-17 / Terminated / root cause: labeling and UDI

FDA source

Abbott Point of Care Inc. began a recall of i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ on 2010-03-17. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0456-2011
Status: Terminated
Initiated: 2010-03-17
Posted: 2010-11-24
Terminated: 2011-09-22
Recalling firm: Abbott Medical
Product: i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
Product code: CGL Electrode, Ion Based, Enzymatic, Creatinine
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 34525 cartridges
Distribution: Worldwide Distribution: Throughout USA and Canada.
Product codes and lots: Lot numbers A09279A and A09280A, Exp March 2010

Product code CGL

K973292Class III-Stat SystemI-Stat Corp. / cleared 1997-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)