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EZ2 Connect MDx

QIAGEN GmbH · Model 9003230 · UDI-DI 04053228040576

JJH Prescription

510(k) clearances

295

Adverse events (1 deaths)

Recalls

Facilities

Description

The EZ2 Connect MDx is a compact benchtop instrument for automated isolation of nucleic acids from up to 24 samples in parallel, using sealed prefilled cartridges The EZ2 Connect MDx system is designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. The EZ2 Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the EZ2 Connect MDx instrument for the applications described in the kit handbooks. The EZ2 Connect MDx system is intended for use by professional operators, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ2 Connect MDx 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.