Class II

Medical Device Recall: EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230

Qiagen Sciences LLC · March 4, 2024

Reason for Recall

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 being processed will be lost

Distribution

Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH

States Affected

NATIONWIDE

Quantity Affected

168 units: 38 units US; 130 units OUS

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1508-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Qiagen Sciences LLC Medical Device Recall: EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230 | SafeCheck