Abbott i-STAT PT/INR Cartridges Recalled for Incorrectly Elevated Results
Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated results, potentially affecting monitoring of patients on anticoagulation therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect medical monitoring) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges due to a potential for the devices to exhibit incorrectly elevated results. These cartridges are used to monitor patients receiving oral anticoagulation therapy, such as Coumadin or warfarin.
The recall involves 2,950,296 cartridges in the United States and 156,408 cartridges outside the United States. The affected lots begin with R11 or R12, and specific list numbers include 04J50-01, 04J5O-02, and 03P89-24. The product was distributed nationwide in the US and worldwide.
Patients and healthcare providers should verify if their cartridges are affected by checking the lot numbers. If a cartridge is part of the recall, it should be returned to Abbott Point of Care Inc. for replacement or refund.
The recalled product
- Product
- I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
- Manufacturer
- Abbott Point Of Care Inc.
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)
- List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12
Distribution
Distributed nationwide across the United States.
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