Abbott recalls i-STAT CG8+ potassium cartridges that may give inaccurate potassium results, especially with low or high potassium samples. Affected units include specific lot numbers and box numbers.
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
Take action
Contact the company
📍Recalling firmAbbott Point Of Care Inc.400 College Rd E · Princeton, NJ 08540-6607
“Abbott i-STAT CG8+ Cartridges: Inaccurate Potassium Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69869-abbott-i-stat-cg8-cartridges-inaccurate-potassium-results-risk. Based on FDA recall #Z-0615-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0615-2019%22&limit=1).
The FDA announced on Sept. 13, 2018, that Abbott Point Of Care Inc. is recalling Abbott i-STAT CG8+ Cartridges due to the hazard of inaccurate potassium results. The agency issued recall number Z-0615-2019 for the voluntary Class II recall.
How to tell if you have it
Brand: Abbott
Product: Abbott i-STAT CG8+ Cartridges
UPC: 10054749000163
List Number/UDI#: 03P88-25, (01)10054749000163(17)181028(10)L18059
The recall cites the hazard that inaccurate potassium results may be generated when testing with control fluid and/or patient samples. Specifically, elevated potassium results may occur with low or reference range concentrations, while decreased results may appear with high concentrations.
Context
GovInfoNow's records show Abbott Point Of Care Inc. has had 8 other recalls on record since Sept. 12, 2017. Other recent recalls of similar products include Abbott i-STAT Cartridges May Show Wrong Blood Gas Results (April 1, 2026), Abbott i-STAT CG4+ Cartridge Recall: Lack of Premarket Clearance (Aug. 21, 2025), and Abbott i-STAT EG6+ Cartridge Recall: Lack of 510(k) Clearance (Aug. 21, 2025). Other recent recalls of similar products include Medica Capillary Tubes Recall: False Potassium Elevation Risk (Dec. 31, 2025), Siemens Dimension Creatinine Flex Reagent Cartridge Recall: Potential Creatinine Measurement Errors (March 18, 2026), and Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall: Potential QC Errors in Patient Results (May 7, 2026).
How to tell if you have this one
Check for lot number L18059 and box numbers 0221-0233 on the cartridge packaging. The list number/UDI# starts with 03P88-25.
Brand
Abbott
Product
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cartridge Lot Number
Look for lot number L18059 on the cartridge packaging.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0615-2019 (September 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0615-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.