| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00470-1 |
| Product Name/Description |
ETEST ETP32 (Ertapenem) WW B30. An in vitro diagnostic medical device (IVD) for Antimicrobial susceptibility testing.
Reference Number: 531600
Multiple Lot Numbers
ARTG Number:187139 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
A bioMérieux investigation has confirmed a potential performance issue on strain categorization for Streptococcus viridans group and Streptococcus pneumoniae based on 2017 CLSI and EUCAST breakpoints, which could lead to False Susceptible result instead of resistant results on ETEST ETP32 blister packaging when comparing to the Broth-Micro Dilution (BMD) reference method. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
bioMérieux is advising customers who use the 2017 CLSI and 2017 EUCAST clinical guidelines that they can continue the use of ETEST ETP32 blister packaging except for Streptococci group including S. pneumoniae strains. bioMérieux is also advising that laboratories should identify any possible false Susceptible results from previously performed tests and analyse the related risks and determine appropriate actions if relevant.
This action has been closed out on 14/11/2018 |
| Contact Information |
1800 333 421 - bioMérieux Help Desk Department |