The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Vitek 2 Gram Positive Susceptibility Test Cards, manufactured by Biomerieux.
The affected devices are identified as follows:-
(AST-P636 REF 417951), (AST-P639 REF 418662), (AST-P640 REF 418579), (AST-P641 REF 418590), (AST-P642 REF 418604), (AST-P643 REF 418671), (AST-P644 REF 418673), (AST-P645 REF 419602), (AST-P646 REF 420144)
According to the FDA, the product inserts fail to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
For details, please refer to the FDA website:
http://www.accessdata.fda.gov/scripts/ires/index.cfm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 May 2016