# P180043: therascreen FGFR RGQ RT-PCR Kit

- Pathway: PMA
- Applicant: QIAGEN GmbH
- Decided: Apr 12, 2019 after 155 days
- Product code: OWD (Somatic Gene Mutation Detection System)
- Device class: 3
- Recalls of this device: 4 (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
- Jul 20, 2022 · Class II · Z-1652-2022: Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to t
- Jul 20, 2022 · Class II · Z-1651-2022: Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to t
- Jul 20, 2022 · Class II · Z-1650-2022: Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to t
- May 6, 2019 · Class II · Z-1891-2019: The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields and less sensitive downstream applications

Source page: https://510kreport.com/device/P180043
Methodology: https://510kreport.com/methodology