Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2582-2025 — i-STAT CG4+ cartridge (white). List Number: 03P85-25.

U.S. FDA — Device Enforcement · United States · 2025-08-21 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2582-2025
Date of alert
2025-08-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Point Of Care Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.