Z-2022-2011

i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions...

Name: Z-2022-2011 i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions...
Creator: Abbott Point Of Care Inc.
Published: 2011-02-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-02-15 / Terminated

FDA source

Abbott Point Of Care Inc. began a recall of 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... on 2011-02-15. The reason FDA records is "i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2022-2011
Status: Terminated
Initiated: 2011-02-15
Posted: 2011-04-18
Terminated: 2012-07-10
Recalling firm: Abbott Medical
Product: 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.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.
FDA root cause: Other
Action: 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.
Quantity in commerce: 6575 cartirdges
Distribution: Nationwide distribution.
Product codes and lots: 510 K053110; Lot # C10247 boxes 0532 through 0593

Product code JGS

K053110Class IIAbbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ CartridgeI-Stat Corporation / cleared 2006-01-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)