Abbott recalls i-STAT CG4+ blue cartridges (List No. 03P85-50) 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 i-STAT CG4+ blue cartridges because they are not FDA cleared and do not have CLIA waived status. This means they cannot be legally used in labs that require waived tests, potentially leading to incorrect medical results.
The i-STAT CG4+ blue cartridge is intended for measuring lactate, pH, pCO2, and pO2 in blood. However, it lacks FDA clearance and CLIA waived status, meaning it cannot be legally used in labs that require waived tests. This could lead to incorrect medical results if used improperly.
Healthcare facilities using the i-STAT CG4+ blue cartridges for blood testing may be affected. Clinicians and lab staff who use these cartridges for lactate, pH, and other blood measurements are most at risk.
Check for the blue i-STAT CG4+ cartridge with List No. 03P85-50 and UDI (01) 00054749002269. All lots of this product are affected.
Identify the blue i-STAT CG4+ cartridge with List No. 03P85-50 and UDI (01) 00054749002269.
The i-STAT CG4+ blue cartridge is not FDA cleared and lacks CLIA waived status, meaning it cannot be legally used in labs that require waived tests.
Healthcare facilities using this cartridge for blood testing may face incorrect results if they use it without proper regulatory clearance.
The official recall does not provide a remedy; all affected cartridges must be identified and stopped from use.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1263-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1263-2020 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.
