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.
Abbott is recalling all blue i-STAT G3+ cartridges because they were marketed without enough clinical evidence to ensure safety and proper function. This means the cartridges could pose risks if used without the required testing.
The blue i-STAT G3+ cartridges were marketed without sufficient clinical evidence to prove they work safely and correctly. This means they might not provide accurate blood test results, which could lead to incorrect medical decisions.
Healthcare professionals and labs using the blue i-STAT G3+ cartridges are affected. Those who have the cartridges are at risk if they continue using them without proper evidence of safety.
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.
The blue i-STAT G3+ cartridges were recalled due to insufficient clinical evidence for safety and performance. Do not use them.
Abbott determined that the blue i-STAT G3+ cartridges were marketed without sufficient clinical evidence to ensure safety and proper function.
Yes, all lots of the blue i-STAT G3+ cartridges with List No. 03P78-50 and UDI (01) 00054749002283 are affected.
Stop using the cartridge immediately and contact Abbott for further instructions.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1265-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1265-2020 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.
