FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0456-2011
- Recalling firm
- Abbott Point of Care Inc.
- Product
- i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
- Status
- Terminated
- Initiated
- 2010-03-17
- Posted
- 2010-11-24
- Terminated
- 2011-09-22
- 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.
- Lot, serial or model codes
- Lot numbers A09279A and A09280A, Exp March 2010
- 510(k) numbers
- ["K973292"]
- PMA numbers
- not on file
- Product code
- CGL
- Firm FEI
- 2245578
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28