Abbott i-STAT Product Notification

DHS Logo Original 07/11/2018

Division of Quality Assurance: Notifications & Updates

Attn: All Wisconsin Providers Performing Laboratory Testing on the Abbott i-STAT

Abbott i-STAT Product Notification

This notification is for providers performing laboratory testing using the Abbott i-STAT Chem8+ cartridges (blue) and CG4+ cartridges (blue).  These cartridges have not obtained approval from the Food and Drug Administration (FDA) and therefore are not classified as waived testing but rather high complexity testing.

For product questions and additional information of all products affected, please contact Abbott Point of Care Technical Support through their website at

For regulatory questions please contact the Center for Medicare and Medicaid Services (CMS) at