Recall of i-STAT G3+ Cartridges by Abbott

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Abbott Point of Care Inc. is recalling 40,275 units of i-STAT G3+ cartridges in the US due to potential inaccurate blood gas results from a manufacturing issue.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Abbott Point of Care Inc. is voluntarily recalling certain lots of i-STAT G3+ cartridges because approximately 7.6% of cartridges may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. This could lead to misdiagnosis, such as indicating severe respiratory acidosis.

Which Products Are Affected

The affected product is the i-STAT G3+ cartridge with List Number: 03P78-26, UDI-DI: 00054749005673, and Lot number: N25221. A total of 40,275 units in the United States are affected, with distribution nationwide in the US and other countries, though the recall focuses on US units.

What You Should Do

Customers who have received the initial letter from Abbott Point of Care Inc. should follow the instructions provided in that letter. For more information, contact the recalling firm.

Why This Matters

This recall is significant because inaccurate test results could result in unnecessary medical interventions, potentially causing harm to patients through overcorrection or delays in proper treatment.

Source

This information is from the FDA recall announcement, recall number Z-2001-2026. For details, visit the FDA website at https://www.fda.gov/.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Abbott Point of Care Inc. is recalling 40,275 units of i-STAT G3+ cartridges in the US due to potential inaccurate blood gas results from a manufacturing issue.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.