Drug & Device Safety Atlas

FDA recall record · openFDA

Abbott Point Of Care Inc.

7 FDA recalls on record (2025–2026) — 7 device. 7 still ongoing.

0
Class I (most serious)
7
Class II
0
Class III
7
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for po 3
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) an 3
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measur 1

Recalls

i-STAT G3+ cartridge; List Number: 03P78-26; Class II 2026-04-01 i-STAT EG7+ cartridge; List Number: 03P76-25; Class II 2026-04-01 i-STAT EG6+ cartridge; List Number: 03P77-25; Class II 2026-04-01 i-STAT EG6+ cartridge. List Number: 03P77-25. Class II 2025-08-21 i-STAT CG4+ cartridge (white). List Number: 03P85-25. Class II 2025-08-21 i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300 Class II 2025-08-21 i-STAT EG7+ cartridge. List Number: 03P76-25. Class II 2025-08-21

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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