FDA recall Z-2582-2025

Abbott Point Of Care Inc. · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-08-21
Report date
2025-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2582-2025