NEW YORK – Abbott has told its customers not to use its i-Stat Blue Chem8+ and CG4+ cartridges, following discussions with the US Food and Drug Administration.
The assays are modified versions of the White i-Stat Chem8+ and CG4+ cartridges, which were both FDA cleared and CLIA-waived. The i-Stat Chem8+ cartridge contained nine assays, while the i-Stat CG4+ cartridge had four assays.
In its notification letter posted on Abbott's website Wednesday, the company said that it made changes to the cartridges and marketed them as the Blue Chem8+ and CG4+ cartridges, but after the modifications were made, Abbott noticed performance changes in the cartridges.
A spokesperson for the Abbott Park, Illinois-based company said in an email that it did not submit new 510(k) applications to the FDA for the revised cartridges because it believed it wasn't required to do so. It discovered later it was. Abbott noted it received no reports of patient harm due to the performance changes.
After discussions with the FDA, Abbott has filed a 510(k) notification seeking FDA-clearance for the Blue Chem8+ cartridges for use with venous and arterial specimens.
The company said it also plans to pursue clearance for the Blue CG4+ cartridges for use with venous and arterial specimens after finishing ongoing studies.
It has decided not to pursue FDA clearance for either cartridge for use with capillary blood samples because it "does not currently have the data necessary to demonstrate performance with capillary blood," it said in the notification letter.
Abbott doesn't plan to purse CLIA-waived status for the Chem8+ cartridges, but said it is working with the FDA to bring the cartridges into compliance with all regulatory requirements and "plans to submit this as a recall."
The company said labs in CLIA-waived settings that use the cartridges should transition to alternate CLIA-waived testing methods or have a reference laboratory perform the appropriate tests. Companies should discontinue use of the cartridges with capillary samples, Abbott added. For labs using the cartridges with venous and arterial specimens, an alternate method should be used, although the cartridges will still be available as the company tries to get FDA clearance for facilities in non-waived settings.