| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01142-1 |
| Product Name/Description |
Sensitest Agar
Product Code: 04134
All lot numbers affected
ARTG Number: 201986 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed-out on 22/03/2018. |
| Contact Information |
1800 333 421 - BioMérieux Helpdesk |