Medical device manufacturer, BioMerieux, has issued a medical device safety alert concerning its Muller Hinton 2 agar + 5% sheep blood [Reference number: 43329, 43321 and 43324].
During an internal investigation, the manufacturer observed that the use of the medium Mueller Hinton 2 agar + 5% sheep blood (MH-S) (Ref. 43329-43321-43324) with the Cotrimoxazole antibiotic (= Trimethoprime-sulfamethoxazole) (SXT) could lead to false susceptible results for S. pneumonia and Streptococci strains with a disc diffusion method whatever is the shelf-life of the media.
According to the manufacturer, results for others combinations strains-antibiotics that could be tested on MH-S medium (Ref. 43321-43329-43324) are conform to the expected results. Results on (MH2-F) (Ref. 41864) bottle and Mueller Hinton 2 Agar (MH2-D) (Ref. 51075-51860) regarding the SXT antibiotic are conform to the expected results
The manufacturer is advising users do not use the affected products with the SXT antibiotic whatever the strain that could be tested. The users can use (MH2-F) (Ref. 41864) bottle and Mueller Hinton 2 Agar (MH2-D) (Ref. 51075-51860) with 5% sheep blood with the SXT antibiotic as products performed within the specifications.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 August 2016