# P040018: Advia Centaur Hav Igm Ready Pack Reagents, Advia Centaur Hav Igm Quality Control Materials

- Pathway: PMA
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 22, 2004 after 265 days
- Product code: LOL (Hepatitis A Test (Antibody And Igm Antibody))
- Device class: 2
- Regulation: 21 CFR 866.3310
- 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
- Jan 12, 2008 · Not classified · Z-1119-2008: Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.

Source page: https://510kreport.com/device/P040018
Methodology: https://510kreport.com/methodology