Device product

i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Z-2582-2025

August 21, 2025

Class II

Product summary

Firm: Abbott Point Of Care Inc.
Event: Event 97442
Status: Ongoing
Classification: Class II
Quantity: 9,067,050 units
Official record key: device-enforcement:Z-2582-2025

Official wording

Reason: Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

Code information: List Number: 03P85-25. 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 CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.