Lower riskMedical device recall · FDA · Published January 14, 2020
Abbott i-STAT G3+ Blue Cartridge Recall: Missing Clinical Evidence
Abbott recalls blue i-STAT G3+ cartridges due to insufficient clinical evidence for safety and performance. All units are affected; stop using immediately to avoid potential risks.
Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.
Take action
Contact the company
📍Recalling firmAbbott Point Of Care Inc.400 College Rd E · Princeton, NJ 08540-6607
“Abbott i-STAT G3+ Blue Cartridge Recall: Missing Clinical Evidence.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66049-abbott-i-stat-g3-blue-cartridge-recall-missing-clinical-evidence. Based on FDA recall #Z-1265-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1265-2020%22&limit=1).
The FDA announced on Jan. 14, 2020, that Abbott Point Of Care Inc. is recalling blue i-STAT G3+ cartridges because they were marketed without a 510(k) premarket clearance. The agency stated Abbott lacks sufficient clinical evidence to characterize the performance of these devices.
How to tell if you have it
Brand: Abbott
Product: i-STAT G3+ cartridge (blue)
List No.: 03P78-50
UDI (01): 00054749002283
UPC: 00054749002283
Affected lots: All lots
The hazard
According to the FDA, Abbott Point of Care determined it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges. Consequently, the company will no longer distribute the product in the United States as of May 1, 2020.
Context
GovInfoNow's records show Abbott Point Of Care Inc. has had 8 other recalls on record since Sept. 12, 2017. Other recent recalls include Abbott i-STAT G3+ Cartridges May Show Wrong Blood Gas Results (April 1, 2026), Abbott i-STAT EG7+ Cartridge Recall: Lack of Premarket Clearance (Aug. 21, 2025), and Abbott i-STAT CG4+ Cartridge Recall: Lack of Premarket Clearance (Aug. 21, 2025). Other recent recalls of similar products include GET TESTED D-Dimer Test Recall (Nov. 3, 2025), Vivoo Test Strips Recall (Nov. 22, 2025), and FreeStyle Libre 14 Day Sensor Recall (Nov. 24, 2025).
How to tell if you have this one
Look for blue i-STAT G3+ cartridges with List No. 03P78-50 and UDI (01) 00054749002283. All lots are affected, so any blue cartridges of this model are included in the recall.
Brand
Abbott
Product
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
The blue i-STAT G3+ cartridges were recalled due to insufficient clinical evidence for safety and performance. Do not use them.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 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-1265-2020 (January 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1265-2020 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.