Abbott recalls i-STAT CG4+ white cartridges due to missing 510(k) premarket clearance for updated lactate and pH/PO2 measurements. No immediate action needed.
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Abbott is recalling i-STAT CG4+ white cartridges because they lack proper premarket clearance for updated lactate and pH/PO2 measurements. This recall does not pose a safety risk to users.
The cartridges lack 51:0(k) premarket clearance for updated sample types and measurement ranges. This means they were not approved for the specific lactate and pH/PO2 testing they perform. However, the recall does not indicate any safety risk to users.
Users of i-STAT CG4+ white cartridges may be affected. Healthcare professionals using these cartridges for lab testing are most at risk.
Check for i-STAT CG4+ white cartridges with list number 03P85-25. All lot numbers are affected.
Verify the list number 03P85-25 and white color for affected cartridges.
No, the recall does not indicate any safety risk to users.
No immediate action is needed as the recall does not pose a safety risk.
The official notice does not specify a disposal or return action.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2582-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2582-2025 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
