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
FDA Recall Z-1508-2024 · Posted 2024-04-10
Recalling FirmQiagen Sciences LLC
Recall StatusOpen, Classified
Product CodeJJH
Date Initiated2024-03-04
Product Quantity168 units: 38 units US; 130 units OUS
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
Firm Action
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]
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.