EZ1 Advanced XL instrument. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2018-RN-00843-1

Class II

2018-06-29

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00843-1

Qiagen have identified an issue regarding the power branching printed circuit board (pcb) within the ez1 advanced xl instrument. occasionally this has the potential to trigger a malfunction of the instrument heater. nucleic acid extractions processed during failure of the instrument could be compromised and extractions need to be repeated.To date, no adverse events have been reported as a result of this issue.

Qiagen are advising they will replace the faulty component in all potentially affected instruments. Until devices have been corrected, users are advised to complete the following test after every run: 1. Put any EZ1 XL Card into the instrument; 2. Select “3” in the main menu to select test functions; 3. Press ”2” in the test screen to choose the “Temp” operation; 4. Set the temperature to “40.0” degrees; 5. Press “START”; then Observe the “actual” temperature which is displayed. This should rise to 40.0 C +/- 2 degrees within 2 minutes, and an “O” should be displayed next to the temperature value. In the event that the “actual” temperature does not rise to 40.0 C, an “X” continues to be displayed next to the temperature value, this indicates that the instrument is affected by this issue. In this case the nucleic acid eluate from the previous run should be rejected and the sample reprocessed. Contact technical services to arrange a replacement of the faulty component.