i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02 recallZ-0456-2011 · Abbott Point of Care Inc. · initiated Mar 17, 2010
Terminated All recalls posted in November 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Point of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0456-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 17, 2010
- Posted by the FDA
- Nov 24, 2010
- Recalling firm
- Abbott Point of Care Inc.
- Quantity
- 34525 cartridges
- Product code
- CGL
- FDA submissions
- K973292
- Distribution
- Worldwide Distribution: Throughout USA and Canada.
Product description
i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
Code information (models, lots, serial numbers)
Lot numbers A09279A and A09280A, Exp March 2010
Other devices under the same FDA submission
1 device cleared under K973292 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- i-STAT 03P84-25Abbott Point Of Care Inc. · ELECTRODE, ION BASED, ENZYMATIC, CREATININE1 recall34 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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