Recall of i-STAT EG6+ Cartridges by Abbott Point of Care Inc.

Source: FDA · United States

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Abbott Point of Care Inc. is recalling certain lots of i-STAT EG6+ cartridges due to potential inaccuracies in blood gas results that could lead to harmful medical interventions, affecting over 30,000 units worldwide.

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

This notice was issued by FDA on May 14, 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.

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Recall Article

What Happened

Abbott Point of Care Inc. is initiating a recall because approximately 7.6% of cartridges from specific lots of i-STAT EG6+ may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. This could result in misdiagnosis, potentially triggering unnecessary or harmful medical interventions.

Which Products Are Affected

The affected product is the i-STAT EG6+ cartridge with List Number: 03P77-25, UDI-DI: 00054749000050, and Lot number: N25223A. A total of 30,775 units are affected, with 25,625 in the US and 5,150 outside the US. The products were distributed nationwide in the US and to countries including Canada, Austria, Bangladesh, Belgium, Finland, France, Germany, Ireland, Italy, Luxembourg, Mauritius, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.

What You Should Do

Affected parties should follow the initial firm notification, which was sent via letter, for instructions on how to handle the recalled products. This recall is voluntary and firm-initiated.

Why This Matters

This recall matters because inaccurate test results could lead to unnecessary medical treatments or delays in proper care, potentially affecting patient safety in healthcare settings.

Source

This information is from the FDA recall notice, recall number Z-2000-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Abbott Point of Care Inc. is recalling certain lots of i-STAT EG6+ cartridges due to potential inaccuracies in blood gas results that could lead to harmful medical interventions, affecting over 30,000 units worldwide.
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.