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QIAcube Connect MDx

QIAGEN GmbH · Model 1 · UDI-DI 04053228039129

JJH Prescription

510(k) clearances

294

Adverse events (1 deaths)

Recalls

Facilities

Description

The QIAcube Connect MDx system is a fully automated, sample preparation system, processing up to 12 samples using silica spin columns technology. The QIAcube Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the QIAcube Connect MDx system for the protocols described in the instructions for use of the respective kits. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAcube Connect IVD system.

Recalls

Date	Firm	Reason
2024-06-03	Qiagen Sciences LLC	Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Pr
2024-03-04	Qiagen Sciences LLC	Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample b
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2023-02-21	Entopsis , Inc.	Presence of misleading label statements on the product label.
2022-11-02	Qvella Corporation	Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.