| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01171-1 |
| Product Name/Description |
Etest PIPTAZO PTC 256 (used for testing of Enterobacteria strains). An in vitro diagnostic medical device (IVD)
Catalogue Number: 412434, 521418
Multiple Lot Numbers affected
ARTG Number: 187139 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that isolates (Enterobacteria strains) were tested with agar dilution and broth micro dilution reference method:
Using EUCAST breakpoints (MIC< or =8: Susceptible ; MIC>16: Resistant), Etest PIP/TAZO showed a higher frequency of erroneous results, false susceptible results, when comparing to the referenced method (Broth-Micro Dilution).
The risk to patients as a result of the performance shift is the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results. This risk may lead to medical intervention for the patient because the erroneous result could negatively influence the selection of antibiotic therapy. |
| Recall Action |
Recall |
| Recall Action Instructions |
Biomerieux is advising users to discontinue use and discard any remaining units. Biomerieux is advising users to discuss any concerns regarding previously reported results with the Laboratory Medical Director. This action has been closed-out on 31/08/2016. |
| Contact Information |
1800 333 421 - bioMerieux Technical Assistance Department |