| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01530-1 |
| Product Name/Description |
ETEST Teicoplanin 256 (TP) SPB and Foam packaging. An in vitro diagnostic medical device (IVD)
Reference Number: 412461 & 522018
Multiple Serial Numbers
ARTG Number: 187139 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Following an assessment of ETEST Teicoplanin with Staphylococcus spp., biomerieux observed an underestimation of MIC values by at least 1 dilution for Coagulase Negative Staphylococci (CoNS); even though the MIC essential agreement at +/- 1 dilution is > 95% between ETEST TP256 and the reference method Agar Dilution (AD) for Staphylococcus spp.
This underestimation leads to a risk of false Susceptible results linked, in particular to the lack of an Intermediate category interpretation if EUCAST breakpoints are applied for this antibiotic. During the study, the false susceptible rate observed was 37.5% for CoNS, where strains with an MIC at 8 mg/L, by the reference method (Resistant) can be found Susceptible by ETEST Teicoplanin. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
biomerieux is advising users to stop using ETEST Teicoplanin for testing of CoNS and use an alternative method. The test can continue to be used with other microorganisms.
For tests previously performed, users are advised to identify any possible false susceptible results that may have occurred, to analyse the related risks and to determine appropriate actions, if relevant.
This action has been closed out on the 21/11/2018. |
| Contact Information |
1800 333 421 - Technical Support |