| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00352-1 |
| Product Name/Description |
VITEK MS Clinical Systems. An in vitro diagnostic medical device (IVD)
Software version: V2 / KB CLI_2.0 ex-US
Acquisition station: V2.0 : ref 413654, 415706, 417104 and 418884
Software version: V3 / KB CLI_3.0 ex-US
Acquisition station: V3.0: ref: 420260, 421661
ARTG Number: 199422 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
The VITEK MS system could give, in specific conditions, an incorrect identification result if the tested species is not included in the VITEK MS knowledge base (KB). When the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison. Consequently, the system can give:
1) No Identification when the spectrum acquired does not match with any species pattern.
2) A low discrimination identification when the spectrum acquired presents a high level of similarity with multiple specific species patterns present in the database.
3) An incorrect single choice identification to the nearest pattern species when the spectrum acquired presents a high level of similarity with a specific species pattern present in the database.
This is a system limitation with all MALDI-TOF databases which is currently not described in the User Manual. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Biomerieux is advising users to take the limitation (as detailed in the recall notification letter) into account when using the device.
This action has been closed-out on 23/03/2018. |
| Contact Information |
1800 333 421 - Biomerieux Australia Help Desk |