FDA recall Z-2583-2025

Abbott Point Of Care Inc. · Class II · device

Product

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

Reason for recall

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.

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-2583-2025