Abbott Molecular, Inc. is recalling 1,881 units of the Alinity m HCV AMP Kit, which is a diagnostic test used to detect and measure Hepatitis C virus (HCV) in human blood samples. The recall was initiated because of an increase in reports showing reactive negative controls and false positive results in patient samples. This means the test may incorrectly indicate that a patient has Hepatitis C when they do not, which could lead to unnecessary medical treatments or psychological distress. Consumers and laboratories using these specific kits should contact their healthcare provider or Abbott for instructions.
The defect causes the test to produce false positive results, potentially leading to incorrect diagnoses of Hepatitis C and unnecessary medical interventions. Abbott has received reports of these inaccurate results occurring in patient samples when using the affected lots.
Manufacturer notification and correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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