Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges distributed nationwide in the United States. The recall centers on lack of 510(k) clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using the cartridges immediately and follow Abbott’s recall instructions for next steps.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott Point Of Care Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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i-STAT CG8+, EG7+, and EG6+ cartridges are used with Abbott’s i-STAT portable blood analyzer to provide rapid lab results in clinical settings.
The updated sample type and measurement ranges were not cleared by FDA premarket review, potentially affecting test results.
This recall is not part of a broader industry pattern.
Healthcare providers must identify affected lots, stop use, and follow recall procedures to avoid incorrect test readings.
On the cartridge packaging, on Abbott recall notices, and the FDA recall page linked to the 03P76-25 listing.
4-8 weeks for refunds or replacements after eligibility is confirmed.
Keep the recall notice, purchase receipts, packaging photos, and any correspondence with the manufacturer and healthcare providers.
Model numbers: List Number 03P76-25. All lot numbers. Sold: US nationwide distribution. Sold from: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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Abbott Point Of Care recalled 8,962,450 i-STAT CG8+ cartridges sold nationwide in the United States. The recall stems from a lack of FDA 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using these cartridges and follow Abbott's recall instructions.
Abbott Point Of Care recalled 547,250 i-STAT CG8+, EG7+, and EG6+ cartridges distributed nationwide in the United States. The recall concerns lack of 510(k) premarket clearance for updated sample types and measurement ranges. Hospitals and clinicians should stop using these cartridges immediately and follow Abbott’s recall instructions.
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