VITEK MS Clinical Systems. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00909-1

Class II

2017-08-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00909-1

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.

Biomerieux is requesting customers: 1. Distribute the supplied information to all appropriate personnel in your laboratory, retain a copy in your files, and forward the customer letter to all parties that may use this product, including others to whom you may have transferred our product; 2. Take this limitation into account; 3. Contact your local Customer Service in case of questions; and 4. Complete and return the supplied Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice