Recall Z-1508-2024— Qiagen Sciences LLC
Class II · Ongoing
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2024-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. 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.
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-04
- Firm location
- Germantown, MD, United States
Product 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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.