EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic an

FDA device recall Z-1508-2024 · posted 2024-04-10 · Open, Classified

Recall details

Recalling firm

Qiagen Sciences LLC

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

Action taken

Qiagen issued Urgent Medical Device Correction letter to Lab Director/Manager, Medical Director, Risk Manager, Safety Officer on 3/4/24 via email. Letter states reason for recall, health risk and action to take: Complete the Acknowledgment of Receipt promptly and return to quality.communications@qiagen.com. Should the error described above occurs, please perform the following actions: o Switch off the instrument and disconnect from the power supply. o Remove any onboard samples and perform decontamination procedure of the instruments as described in the user manual. o Call your local QIAGEN Technical Service or the Commercial Partner responsible for QIAGEN products in your country. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: " Telephone: (800) 362-7737 " Email: TechService-NA@qiagen.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJH

Quantity affected

168 units: 38 units US; 130 units OUS

Distribution

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

Date initiated

2024-03-04

Date posted

2024-04-10

Location

Germantown, MD