| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00090-1 |
| Product Name/Description |
ETEST Polymyxin B (PO1024) blister packaging. An in vitro diagnostic medical device (IVD)
POLYMYXIN B PO 1024 WW B30
Reference Number: 533400
Batch Numbers: 1005807890, 100575830, 1005497750, 1005161530, 1004414690
POLYMYXIN B PO 1024 WW B100
Reference Number: 533408
Batch Number: 1004530070
ARTG Number: 187139
(Biomerieux Australia Pty Ltd - Antimicrobial susceptibility testing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Following a study conducted on ETEST Polymyxin B with 180 clinical strains (Pseudomonas aeruginosa, Acinetobacter and Enterobacteriaceae), an underestimation of MICs has been observed for Pseudomonas aeruginosa and Acinetobacter species, compared to those obtained using the Broth Micro-Dilution (BMD) reference method. This has led to false susceptible results when the ETEST Polymyxin B results are interpreted using CLSI breakpoints; there are no breakpoints for this drug in the EUCAST guidelines.
As a consequence, ETEST Polymyxin B (Ref. 533400 & 533408) Blister packaging can no longer be recommended for use with Pseudomonas aeruginosa or Acinetobacter strains. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
bioMérieux is advising customers to discontinue use of the ETEST Polymyxin B strips to determine the MICs for Pseudomonas aeruginosa or Acinetobacter species. Laboratories can continue to use ETEST Polymyxin B for Enterobacteriaceae species.
This action has been closed out on 18/02/2019 |
| Contact Information |
02 8852 4700 - Customer Support Centre |