Abbott i-Stat BNP Cartridges Recalled for Atmospheric Pressure Interference
Abbott Point of Care Inc. is recalling i-Stat BNP cartridges because atmospheric pressure can cause suppressed test results, potentially affecting heart failure diagnosis.
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 involves a medical diagnostic device where a defect (suppressed results) could lead to incorrect diagnosis or treatment of a serious condition (congestive heart failure), fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Point of Care Inc. is recalling i-Stat BNP cartridges due to a defect where the frequency of suppressed results is affected by atmospheric pressure. The i-Stat BNP test is an in vitro diagnostic used to measure B-type Natriuretic Peptide (BNP) in whole blood or plasma, which aids in the diagnosis and assessment of congestive heart failure severity.
The recall covers 1,004,200 cartridges in the United States and 54,200 cartridges outside the US. The affected products were distributed worldwide, including in the US states of Arizona and Colorado, and internationally to numerous countries such as Argentina, Australia, Brazil, China, France, Germany, India, Japan, and the United Kingdom. The recall includes all lots of the affected cartridges.
Healthcare providers and laboratories should stop using the affected i-Stat BNP cartridges and contact Abbott Point of Care Inc. for instructions on returning the products. Patients who have had BNP tests performed with these cartridges should consult their healthcare provider to discuss the potential impact on their diagnosis and treatment.
The recalled product
- Product
- i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in
- 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 (4)
- List number 06F30-01
- 06F30-02
- 03P93-25
- 600-9010-25 All lots
Distribution
Part of a larger recall action
This product is one of 3 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.
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