Abbott i-STAT CHEM8+ Cartridges Recalled for Lack of FDA Clearance
Abbott Point Of Care Inc. is recalling i-STAT CHEM8+ cartridges because they are not FDA cleared and do not have CLIA waived status.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard involves regulatory non-compliance (lack of clearance/waived status) rather than a direct physical defect or reported injury.
Plain-English summary
Abbott Point Of Care Inc. is recalling i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. The recall involves 9,049,725 units that were distributed nationwide in the United States. All lots are affected.
The recall was initiated because the i-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. The source text notes that the i-STAT CHEM8+ cartridge contains nine measured assays and is categorized as a CLIA waived test for venous whole blood samples, meaning it could be used in a facility with a CLIA Certificate of Waiver as a waived test.
Healthcare facilities and consumers should stop using the affected cartridges. The source text does not provide specific instructions for returning the product or contacting the manufacturer.
The recalled product
- Product
- i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematoc
- Manufacturer
- Abbott Point Of Care Inc.
- Affected units
- 9,049,725
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots are affected
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Abbott Point Of Care Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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