Recall of i-STAT G3+ Cartridges by Abbott
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,220 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.