# P190025: Alinity m HCV

- Pathway: PMA
- Applicant: Abbott Molecular, Inc.
- Decided: Mar 23, 2020 after 175 days
- Product code: MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus)
- Device class: 2
- Regulation: 21 CFR 866.3170
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K252102: Alinity m HCV (2025), 0 descendants of its own

## Recalls of this device
- Oct 30, 2023 · Class II · Z-0407-2024: 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.
- Dec 9, 2022 · Class II · Z-1009-2023: The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board v
- Nov 11, 2022 · Class II · Z-1349-2023: The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without cal
- Jul 19, 2022 · Class II · Z-1518-2022: Incorrect optical calibration
- Dec 6, 2021 · Class II · Z-0463-2022: There is an issue with the installation of updated camera firmware on the system.

Source page: https://510kreport.com/device/P190025
Methodology: https://510kreport.com/methodology