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Abbott Point Of Care Inc. FDA Recalls
7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| i-STAT EG7+ cartridge; List Number: 03P76-25;Class IIApr 1, 2026Approximately 7.6% of cartridges from specific i-STAT EG7+ ( |
| i-STAT EG6+ cartridge; List Number: 03P77-25;Class IIApr 1, 2026Approximately 7.6% of cartridges from specific i-STAT EG7+ ( |
| i-STAT G3+ cartridge; List Number: 03P78-26;Class IIApr 1, 2026Approximately 7.6% of cartridges from specific i-STAT EG7+ ( |
| i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300Class IIAug 21, 2025Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG |
| i-STAT EG6+ cartridge. List Number: 03P77-25.Class IIAug 21, 2025Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG |
| i-STAT CG4+ cartridge (white). List Number: 03P85-25.Class IIAug 21, 2025Lack of a 510(k) premarket clearance for the i-STAT CG4+ car |
| i-STAT EG7+ cartridge. List Number: 03P76-25.Class IIAug 21, 2025Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG |