# P230003: Alinity m HR HPV

- Pathway: PMA
- Applicant: Abbott Molecular, Inc.
- Decided: Nov 1, 2023 after 274 days
- Product code: MAQ (Kit, Dna Detection, Human Papillomavirus)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Sep 12, 2024 · Class II · Z-0233-2025: Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidate

Source page: https://510kreport.com/device/P230003
Methodology: https://510kreport.com/methodology