| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00185-1 |
| Product Name/Description |
ETEST products. An in vitro diagnostic medical device (IVD).
Ceftazidime TZ256 (F) WW, Ref. 506718
Ceftriaxone TXL32 SPB WW, Ref. 412303
Ceftriaxone TXL32 (F) WW, Ref. 507018
Ciprofloxacin CI 32 (F) WW, Ref. 508610, 508618
Vancomycin VA 256 (F) WW, Ref. 525510, 525518
Benzyl Penicillin PG256 (F) WW, Ref. 502518
Fosfomycin FM1024 (B) WW, Ref. 529100, 529108
Gentamicin GM256 (F) WW, Ref. 512518
Tobramycin TM256 (F) WW, Ref. 522718
Multiple Lot Numbers
ARTG Number: 187139 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
bioMérieux have found that the current shelf-life claims of multiple ETEST products are not supported by internal testing. There is potential to obtain a MIC result that is higher than expected after 24 months for FM1024 (B) WW, after 48 months for GM256 (F) WW and TM256 (F) WW, and after 12 months for the remainder of the affected products. This type of error would be detectable during QC testing as an out of range MIC result would be obtained. Patient results may also be elevated resulting in a false resistant result. Accordingly, the shelf-life claims have been revised to 24, 48 and 12 months, as appropriate. When used within the revised shelf-life, the products will continue to perform per the labelled performance specifications.
For ETEST Ceftriaxone products there is also a potential performance issue on strain categorisation for Streptococcus pneumoniae strains when using the 2016 CLSI or 2016 EUCAST guidelines. There is potential to obtain a false susceptible result. |
| Recall Action |
Recall |
| Recall Action Instructions |
bioMérieux is advising customers to identify impacted lots of the ETEST products and take note of the new expiry dates. Customers are to discontinue using and discard the expired lots. Credit will be provided for expired product. Lots that have remaining shelf life can continue to be used.
For ETEST Ceftriaxone TXL32 SPB WW lots that may have a strain categorisation issue, laboratories can continue to use the ETEST if they apply the recommendations provided in the customer letter. ETEST Ceftriaxone TXL32 (F) WW has been discontinued and customers can transition to ETEST Ceftriaxone TXL32 SPB WW.
It is recommended that customers consider retrospective analysis of patient results.
This action has been closed out on 04/12/2019 |
| Contact Information |
1800 333 421 - bioMérieux Help Desk Department |