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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00843-1
Product Name/Description EZ1 Advanced XL instrument. An in vitro diagnostic medical device (IVD)

Serial Numbers: L16XA1681, L173A1950 and L175A1998

ARTG Number: 221971
(Qiagen Pty Ltd - Instrument/analyser IVDs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/06/2018
Responsible Entity Qiagen Pty Ltd
Reason/Issue 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.
Recall Action Product Defect Correction
Recall Action Instructions 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.

This action has been closed out on 19/02/2019
Contact Information 1800 243 800 - Qiagen