Z-0615-2019Class II

Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial...

Name: Z-0615-2019 Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial...
Creator: Abbott Point Of Care Inc.
Published: 2018-09-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-09-13 / Terminated / root cause: manufacturing process

FDA source

Abbott Point Of Care Inc. began a recall of Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI#... on 2018-09-13. FDA classified it as Class II and gives the reason as "Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0615-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-13
Posted: 2018-12-14
Terminated: 2019-04-04
Recalling firm: Abbott Medical
Product: Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: Abbott Point of Care issued recall letter on 9/13/18 via FedEx , advising of the problem, recommend action to return all unused cartridges to APOC . If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 844-256-9531 or your Abbott Point of Care representative.
Quantity in commerce: 17550 cartridges
Distribution: WI
Product codes and lots: Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0615-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0615-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-14

Product code CHL

K940918Class III-Stat 200 Portable Clinical AnalyzerI-Stat Corp. / cleared 1994-05-10

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)