Sensitest Agar 의 리콜

Recall

RC-2016-RN-01142-1

Class II

2016-09-02

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01142-1

Biomérieux have received reports regarding an issue with the use of biomérieux 04134 sensitest agar. the issue is related to the testing of cefoxitin 10µg disc on staphylococcus aureus yielding zones of inhibition of 5.5 to 6.5 annular radius with isolates of methicillin-resistant staphylococcus aureus (mrsa) (confirmed meca positive). in addition, there are also problems with the lawn growth of staphylococcus intermedius which impacts adversely on susceptibility testing of that organism. the size (<8mm) and morphology of the zone should immediately raise suspicion however, the isolates could be reported as susceptible to cefoxitin (methicillin). therefore, there is the potential for underdiagnoses of mrsa.

As a precautionary measure, BioMérieux is strongly recommending that, as an interim measure while investigations are continuing, to cease using 04134 Sensitest Agar for Staphylococcus sp. and test staphylococci on 04091 Mueller Hinton Agar. It is also recommended that recent results be re-examined using 04091 Mueller Hinton Agar and/or perform MecA testing. Discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. BioMérieux is continuing to investigate the issue in consultation with the Therapeutic Goods Administration (TGA). Further correspondence may be provided following the outcome of the investigations.