FDA recall record · openFDA

Qiagen Sciences LLC

4 FDA recalls on record (2023–2025) — 4 device. 4 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO 1

Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when runn 1

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. 1

Faulty cartridges in the lot could result in false test results. 1

Recalls

Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Versio Class II 2025-03-12 EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic an Class II 2024-03-04 QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu Class II 2024-06-03 QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 Class II 2023-04-28

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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