Lower riskMedical device recall · FDA · Published October 16, 2019
Abbott i-STAT cT:1 Cartridges May Cause Quality Errors - Recall
Abbott recalls i-STAT cTnI blue cartridges that may generate 3-5% quality check errors. Affected units sold with specific list numbers. Consumers should check their cartridges for the listed identifiers.
i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
Take action
Contact the company
📍Recalling firmAbbott Point Of Care Inc.400 College Rd E · Princeton, NJ 08540-6607
“Abbott i-STAT cT:1 Cartridges May Cause Quality Errors - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66783-abbott-i-stat-ct-1-cartridges-may-cause-quality-errors. Based on FDA recall #Z-0761-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0761-2020%22&limit=1).
The FDA announced on 2019-10-16 that Abbott Point Of Care Inc. is recalling i-STAT cTnI cartridges because they may generate a higher than expected number of quality check codes. The recall affects 3,465,875 units distributed across the United States.
How to tell if you have it
Brand: Abbott
Product: i-STAT cTnI cartridge
List Number: 06P23-25
UDI: (01)00054749001986
The hazard
The i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of these codes could be in the 3 to 5% range.
Context
GovInfoNow's records show Abbott Point Of Care Inc. has had 8 other recalls on record since 2017-09-12. Recent recalls include Abbott i-STAT G3+ Cartridges May Show Wrong Blood Gas Results (2026-04-01) and Abbott i-STAT CG4+ Cartridge Recall: Lack of Premarket Clearance (2025-08-21). Other recent recalls of similar products include Abbott ID NOW Influenza A & B 2 Kit: Higher Invalid Rates Risk (2026-02-09), Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall: Potential QC Errors in Patient Results (2026-05-07), and Siemens Dimension Creatinine Flex Reagent Cartridge Recall: Potential Creatinine Measurement Errors (2026-03-18).
How to tell if you have this one
Check for the list number 06P23-25 and unique device identifier (UDI) (01)00054749001986 on the cartridge packaging or label.
Brand
Abbott
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Cartridge Details
Look for the list number 06P23-25 and UDI (01)00054749001986 on the cartridge packaging or label.
Where it went and when
Where it was distributed
Distributed in 33 states and D.C..
Listed by the agency
Not listed
FDA distribution: “US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Mississippi, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wyoming.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0761-2020 (October 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0761-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.