i-STAT CHEM 8+ Cartridge, List Number 03P91-25 recallZ-2022-2011 · Abbott Point Of Care Inc. · initiated Feb 15, 2011
Terminated All recalls posted in April 2011
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
i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.
FDA root cause category: Other
What the company is doing
The firm, Abbott Point of Care (APOC), sent an "Urgent Recall Notice" letter dated February 2011 with business reply cards attached via Fed Ex overnight to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of cartridges from the box numbers of identified lots; discontinue use as a precaution, if their cartridges are no longer traceable to a specific box; return all unused cartridges as instructed on the enclosed Business Reply Card; if they've provided another institution with the cartridges, provide the institution with a copy of this letter, and complete and return the business reply card to APOC. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-336-8020, Option 1 or your Abbott Point of Care representative.
Recall details
- Recall number
- Z-2022-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 15, 2011
- Posted by the FDA
- Apr 18, 2011
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 6575 cartirdges
- Product code
- JGS
- FDA submissions
- K053110
- Distribution
- Nationwide distribution.
Product description
i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
Code information (models, lots, serial numbers)
510 K053110; Lot # C10247 boxes 0532 through 0593
Other devices under the same FDA submission
1 device cleared under K053110 — 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 09P31-25Abbott Point Of Care Inc. · ELECTRODE, ION SPECIFIC, SODIUM423 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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