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.
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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The i-STAT system uses disposable cartridges for point-of-care blood analysis in clinical settings. These cartridges are used with portable analyzers to rapidly measure various analytes and blood gas parameters.
The hazard stems from the lack of regulatory clearance for updated cartridge types and measurement ranges. This could lead to regulatory noncompliance and potential uncertainty in diagnostic results.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to halt use of these cartridges, potentially affecting testing workflows and requiring regulatory coordination.
Refer to the recall notice and Abbott communications for identification codes beyond List Number 03P77-25.
Remediation timelines are set by Abbott and regulators; expect guidance to be issued by the manufacturer.
Record lot numbers, List Number 03P77-25, dates of inventory, communications with Abbott, and internal decisions regarding use or disposal.
Model numbers: List Number 03P77-25. All lot numbers. Distribution: US nationwide. Sold since: 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.
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