Medical device manufacturer, BioMérieux, has issued a medical device safety alert concerning certain lots of chromID S. aureus agar [Catalogue no.: 43371; Lot no.: All].
The manufacturer detected a sensitivity issue on chromID S. aureus agar (SAID) reference 43371: weak growth of Staphylococcus aureus with a non-characteristic color at 24 hours from specimen samples or S. aureus ATCC 25923 (Quality Control strain).
The potential risk associated to this issue is reporting false negative results at 24 hours. As the package insert requires the identification of all colonies other than green ones (white, pink or mauve), S. aureus with a non-characteristic color will be systematically detected.
According to the manufacturer's investigation results, a modification of the package insert will be implemented.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 August 2013