| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00438-1 |
| Product Name/Description |
QIAcube Connect MDx instrument. An in vitro diagnostic medical device (IVD)
Cat number: 9003070
ARTG 221969
(Qiagen Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
An unexpected instrument software problem may affect the applications described below:
QIAamp DSP DNA Mini Kit (Cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria
(Script filename: Kt_name_Bacteria (Gram+) or Yeast_Enzymatic Lysis_V2).
The heater shaker module does not perform heating if the temperature is set below 40°C for static incubation steps when running these protocols.
If running in the Research mode, the following non-IVD applications are affected in the same way:
QIAamp DNA Mini Kit (cat. no. 51304, 51306, and 51326) and DNeasy® Blood & Tissue Kit (Cat. no. 69504 and 69516) (Script filenames: Kit_name_Bacteria_Gram-positive_Or Yeast_EnzymaticLysis_V1).
Other kits and protocols that can be selected in the IVD mode are not affected by this problem.
Temperatures selected at or above 40°C are not affected and do perform as expected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
- If running the listed protocols and the incubation temperature for the bacterial lysis has been set to below 40°C, then the precise temperature control can be set manually by using the heater shaker run module option built into the instrument.
- In the Tools menu of the software, to run the protocol without the affected lysis step (after separate pre-lysis), customers are to select 0 seconds for the incubation time.
-If wishing to check the actual applied temperature in their workflow as currently used, customers should contact a local QIAGEN Technical Service representative to analyse customers' logfiles and determine the actual applied temperature.
This may help to confirm the settings.
This is only an interim solution until the new QIAcube Connect MDx software update is issued. |
| Contact Information |
1800 243 066 - QIAGEN Technical Service Department |