Recall Z-1508-2024 ยท JJH Clinical Sample Concentrator
Qiagen Sciences LLC
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
| Date | Apr 10, 2024 (initiated Mar 4, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by 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 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 Te |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.