Abbott Point Of Care Inc. recalls i-STAT CG4+ cartridge (white). List Number: 03P85-25.
- Recall date
- August 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2582-2025
- FDA classification
- Class II
- Brand / firm
- Abbott Point Of Care Inc.
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
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