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Urgent Recall Memo: i-STAT CHEM8+ Recall Notification
Abbott Point of Care has issued a product notification for the CHEM8+ i-STAT cartridges that are used at some UCI sites. Although these cartridges were previously marketed as CLIA-waived, some modifications have resulted in changes to the cartridges, which were not submitted to the FDA.

Currently, CHEM8+ cartridges have not been cleared by the FDA for testing. Abbott has issued a product notification of plans to submit a recall while working with the FDA to obtain clearance for non-waived settings. In order to mitigate risk associated with the performance of these products not being fully characterized, all sites should discontinue using i-STAT CHEM8+ until these cartridges have been appropriately cleared by the FDA. Once these devices are approved, sites with CLIA non-waived status will need to document training and competency according to the regulatory requirements for moderate complexity testing before resuming testing.

This notice does not apply to i-STAT CG8+ cartridges or creatinine cartridges. Non-waived point of care sites whose clinical needs can be met with the CG8+ cartridge menu (includes: pH, PCO2, PO2, Na, K, ionized calcium, hematocrit) can be transitioned to this cartridge, but only if training and competency using the CG8+ cartridge are documented. Tests not included in CG8+ or creatinine should be ordered as stat and sent to the main laboratory. Non-waived sites may use the CG8+ cartridge after training is completed.

Known UCI locations that have the CHEM8+ i-STAT cartridges:

Waived license sitesdiscontinue immediately, send specimen to main lab:
  • UCI Pavilion 3 Surgical Clinic
  • Gavin Herbert Eye Institute

Non-waived license sitesdiscontinue immediately, send specimen to main lab or use the CG8+ cartridge only if training and competency using the CG8+ cartridge are documented:
  • Chao Infusion Center
  • CDDC GI Lab
  • DH PPC

Effective date: Jan. 15, 2020

Abbott Point of Care, Inc. Urgent product corrective action APOC2020-001


Bridgit O. Crews, PhD, DABCC
Clinical Chemistry and Toxicology

Edwin S. Monuki, MD, PhD
Department of Pathology & Laboratory Medicine
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