Abbott recalls blue i-STAT CHEM8+ cartridges (List No. 09P31-25) as they are not FDA cleared and lack CLIA waived status, risking improper lab testing.
The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.
Abbott is recalling blue i-STAT CHEM8+ cartridges because they are not FDA cleared and do not have CLIA waived status. This means they could be used in facilities with CLIA waivers, which is not permitted under current regulations.
The cartridges are not FDA cleared and lack CLIA waived status. CLIA requires specific lab testing standards, and using these cartridges in facilities with waived status could lead to incorrect test results.
Healthcare facilities using these cartridges for blood tests may be affected. Patients using these cartridges for home testing are at higher risk due to potential improper results.
Look for blue i-STAT CHEM8+ cartridges with List No. 09P31-25 and UDI (01) 00054749001910. All lots of this product are affected.
Identify blue i-STAT CHEM8+ cartridges with List No. 09P31-25 and UDI (01) 00054749001910.
No, these cartridges are not FDA cleared and lack CLIA waived status, so they cannot be used in facilities with CLIA waivers.
The recall states all lots are affected, so you should check if you have these cartridges and follow the action steps.
The recall does not specify a remedy, so contact Abbott for guidance on handling the cartridges.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1262-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1262-2020 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.
