Abbott Recalls i-Stat PT/INR Cartridges Due to Test Delays
Abbott Point Of Care Inc. is recalling specific lots of i-Stat PT/INR Cartridges because they may generate excessive star outs, potentially delaying patient results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text describes a functional defect (test delays) rather than a direct safety hazard like injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Point Of Care Inc. is recalling 423,168 i-Stat PT/INR Cartridges. The affected products are identified by list number 03P89-24 and include all lots from S15007 to S15026 inclusive and all lots from T15037A to T15076A inclusive. These cartridges are used for prothrombin time testing to monitor patients receiving oral anticoagulation therapy, such as coumadin or warfarin.
The recall was initiated because certain lots of the cartridges may generate a higher than typical number of PT/INR star outs. This issue potentially delays the generation of patient results. The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as China, Lebanon, Costa Rica, Singapore, Brazil, and others.
Healthcare facilities and distributors should stop using the affected cartridges and contact Abbott Point Of Care Inc. for further instructions. Patients should consult their healthcare providers regarding any delays in their test results.
The recalled product
- Product
- i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
- Affected units
- 423,168
Distribution
Distributed nationwide across the United States.
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