| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00136-1 |
| Product Name/Description |
ETEST XM256 (Cefuroxime) Foam and SPB. An in vitro diagnostic medical device (IVD).
ETEST XM256 (Cefuroxime) WW SPB
Reference Number: 412305
Lot Numbers: 1002884720 (Exp. 16 Jan 2017), 1003383650 (Exp. 27 Aug 2017)
ETEST XM256 (Cefuroxime) WW Foam
Reference Number: 506918
Lot Numbers: 1003075850 (Exp. 9 April 2017), 1003385930 (Exp. 27 Aug 2017)
ARTG Number: 187139
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
A bioMérieux investigation has confirmed a potential performance issue on strain categorisation for Streptococcus pneumoniae and for Enterobacteriaceae strains limited to oral cefuroxim breakpoints based on 2016 CLSI clinical standards. The potential hazard is to obtain Minor error (Susceptible instead of Intermediate or Intermediate instead of Resistant) on strain categorisation for Streptococcus pneumoniae and for Enterobacteriaceae strains only when using the 2016 CLSI clinical breakpoints defined for cefuroxime oral forms. Products perform within specification when using the 2016 EUCAST guidelines. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
bioMérieux is advising customers who use the 2016 CLSI clinical guidelines that they may continue to use the ETEST XM256 (Cefuroxime) Foam and SPB products and can directly report results for Streptococcus pneumoniae and Enterobacteriaeceae when oral breakpoints are used if they apply the reporting recommendations provided in the customer letter. bioMérieux is also advising that for tests previously performed, users are to identify any possible false Susceptible results, analyse the related risks and determine appropriate actions if relevant.
This action has been closed-out on 27/03/2018. |
| Contact Information |
1800 333 421 - bioMérieux help desk department |