# P090026: Access Hybritech P2PSA on the Access Immunoassay Systems

- Pathway: PMA
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 14, 2012 after 940 days
- Product code: OYA (P2psa)
- 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
- May 17, 2023 · Class II · Z-2043-2023: Reagent lot numbers include an insufficient concentration of blocking reagent.

Source page: https://510kreport.com/device/P090026
Methodology: https://510kreport.com/methodology