FDA recall Z-2585-2025

Abbott Point Of Care Inc. · Class II · device

Product

i-STAT EG6+ cartridge. List Number: 03P77-25.

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-2585-2025