| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00160-1 |
| Product Name/Description |
EZ2 Connect MDx instrument. An in vitro diagnostic medical device (IVD)
Cat number: 9003230
Serial number: P0823002M, P0923037M, P0523108M, P0722016M
ARTG 221969
(Qiagen Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Potential for the heater cable of the EZ2 Connect MDx instrument to become brittle. The issue is caused by insufficient welding between the heater cable and the heater plate on the heater system. The insufficient welding leads to the heater cable becoming brittle and as a consequent disintegration of the cable. If not spotted early by a field service engineer during a service visit, may cause the instrument to present with the following error: ERROR 3481 – HEATER UNABLE TO REACH TEMPERATURE.
If Error 3481 is displayed while the instrument is in use, sample loss could occur which may delay test results. QIAGEN has calculated that the probability of an instrument demonstrating Error 3481 is approximately 0.35%. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Heater modules in all instruments supplied in Australia will be replaced by qualified field service engineers.
Should the error described above occur, please perform the following actions:
o Switch off the instrument and disconnect from the power supply.
o Remove any onboard samples and perform the decontamination procedure of the instrument as described in the user manual.
o Call the QIAGEN Technical Service responsible for QIAGEN products in Australia on 1800 243 066 |
| Contact Information |
1800 243 066 - QIAGEN |