Abbott i-STAT CG4+ Cartridges Recalled for Lack of FDA Clearance
Abbott Point Of Care Inc. is recalling i-STAT CG4+ cartridges because they are not FDA cleared and lack 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 a voluntary precautionary measure addressing regulatory compliance (lack of FDA clearance/CLIA status) without reported illnesses or injuries, fitting the Moderate criteria for low-risk or documentation issues.
Plain-English summary
Abbott Point Of Care Inc. is recalling 99,850 units of the i-STAT CG4+ cartridge (blue), List No. 03P85-50. The recall is due to the fact that the i-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
The source text notes that CLIA recognizes two types of laboratory tests: waived and non-waived, with different standards applying to each. While the i-STAT CHEM8+ cartridge is categorized as a CLIA waived test for venous whole blood samples, the CG4+ cartridge lacks this status. All lots are affected, and the products were distributed nationwide in the US.
Consumers and facilities should stop using the affected i-STAT CG4+ cartridges. The recall is driven by regulatory compliance issues regarding FDA clearance and CLIA status rather than reported product defects or patient injuries.
The recalled product
- Product
- i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
- Manufacturer
- Abbott Point Of Care Inc.
- Affected units
- 99,850
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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