Recall Z-0407-2024— Abbott Molecular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2023-10-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.. Reason: Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-30
- Firm location
- Des Plaines, IL, United States
Product description
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
Reason for recall
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.