Abbott i-STAT PT/INR Cartridges Recalled for Potential INR Errors
Abbott Point of Care Inc. is recalling i-STAT PT/INR cartridges because they may display incorrectly elevated INR 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 3/5 (High).
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 involves a medical device used for critical patient monitoring where incorrect results could lead to improper treatment, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abbott Point of Care Inc. (APOC) is recalling i-STAT PT/INR cartridges due to a potential defect that may cause the devices to exhibit incorrectly elevated International Normalized Ratio (INR) results. The i-STAT PT/INR test is used by trained health care professionals to monitor patients receiving oral anticoagulation therapy, such as Coumadin or Warfarin.
The recall affects 794,928 units distributed in the United States and 119,472 units distributed internationally. The affected products include specific lot numbers and cartridge lots ranging from C13139 up to and including C13270A. Distribution was worldwide, including the US and numerous international markets.
Health care facilities should stop using the affected cartridges and contact Abbott Point of Care Inc. for instructions on returning or replacing the products. Patients should consult their healthcare providers regarding their anticoagulation therapy monitoring.
The recalled product
- Product
- Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer…
- Manufacturer
- Abbott Point Of Care Inc.
- Hazard
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 (5)
- K020355 List number 04J50-01
- 04J50-02
- 03P89-24 Lot number R13149A
- R13151
- R13151A and cartridge lots from C13139 up to and including C13270A
Distribution
Distributed nationwide across the United States.
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