| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01051-1 |
| Product Name/Description |
VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (an in vitro diagnostic medical device (IVD))
Catalogue Number: 410895
Serial Numbers: Lower than #50039, #50050, greater than or equal to #60000
ARTG Number: 199422 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Some issues have been reported when firmware version 3.13 was installed on systems equipped with the old Transient Recorder (TR) Board (ref. 6200350). Extensive testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old TR board, with a risk of repeated results for different spots. This issue does not occur if firmware version 3.13 is installed with the new TR board AE8679AD (ref. 6200720). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Biomerieux is requesting users to reboot the instrument if the board freezes. Biomerieux is advising users that the new TR board is required to have firmware V3.13, and the old TR board is required to have firmware version V3.10. Biomerieux is contacting users to migrate the firmware if required. |
| Contact Information |
1800 333 421 - bioMerieux Technical Assistance Department |