Abbott i-STAT® and CHEM8+ and CG4+ cartridges

On January 15, 2020, Abbott sent an urgent notice to all laboratories using i-STAT® devices regarding the use of their CHEM8+ and CG4+ cartridges. According to the linked bulletin, the iSTAT BLUE CHEM8+ and CG4+ cartridges are not currently FDA-cleared and do not have CLIA waived status.

As a result, we are recommending that all COLA-accredited laboratories discontinue use of the affected cartridges and contact Abbott and other laboratory instrument manufacturers for alternative testing options that fit their laboratory’s needs and CLIA complexity. Laboratories are encouraged to contact COLA’s TA team for assistance,  in validating a new alternative test system, once one has been selected.

COLA Inc. can also provide information needed if you decide to change from a Certificate of Waiver to a Certificate of Accreditation. We are committed to assisting laboratories with providing the highest quality, near-patient test results.

You can reach a Technical Advisor for assistance here or by calling 800-981-9883.

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