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Recall Observatory FDA recall evidence

Device product

i-STAT EG7+ cartridge. List Number: 03P76-25.

Z-2584-2025

August 21, 2025

Class II

Product summary

Firm
Abbott Point Of Care Inc.
Event
Event 97443
Status
Ongoing
Classification
Class II
Quantity
6,115,950 units
Official record key
device-enforcement:Z-2584-2025

Official wording

Reason: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

Code information: List Number: 03P76-25. All lot numbers.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.