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
Recall
- Recall Number
- Z-1508-2024
- Event Number
- 94254
- Firm
- Qiagen Sciences LLC
- FEI Number
- 3003572099
- Product Code
- JJH
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 4, 2024
- Posted
- April 10, 2024
- Address
- 19300 Germantown Rd, Germantown, MD, 20874-1415
Description
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
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
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 [email protected]. 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: [email protected]
Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH
168 units: 38 units US; 130 units OUS