FDA Device Intelligence
Home › Device types › QDS

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

FDA product code QDS · Class 2 · Pathology

2
Registered devices
7
Adverse events
5
Recalls
3
510(k) clearances

Devices with this code

FilmArray® Pneumonia Panel plus (Pneumoplus) — BIOFIRE DIAGNOSTICS, LLCFilmArray® Pneumonia Panel plus (Pneumoplus) — BIOFIRE DIAGNOSTICS, LLC

Recent recalls

DateFirmReason
2025-02-27BioFire Diagnostics, LLCIncreased risk of control failures and false negative test results with multiplexed nucleic acid test.
2024-06-10BioFire Diagnostics, LLCPneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
2024-06-10BioFire Diagnostics, LLCPneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
2023-12-14BioFire Diagnostics, LLCTheir is a potential for false positive results when using Pneumonia panel.
2021-06-07BioFire Diagnostics, LLCDue to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.