| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00072-1 |
| Product Name/Description |
BD Phoenix Gram Negative Panels containing colistin.
(An in vitro medical device)
Catalogue Number: 448788
Lot Numbers: ALL
ARTG Number 197287 (Becton Dickinson Pty Ltd - Antimicrobial susceptibility testing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
As a result of continuous surveillance on antimicrobial resistance, Becton Dickinson (BD) are aware of newly recognised or emerging strains that may yield an increased rate of false susceptibility in in vitro antimicrobial susceptibility test (AST) results to colistin.
The Labelling currently provided with the BD Gram Negative Panels (NMIC) panels indicates that colistin susceptibility can be determined. Emerging strains have led to an increased number of resistant isolates reporting as susceptible when tested using the BD NMIC panels with BD Phoenix instrumentation
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
BD is advising users to perform an alternate method of testing prior to reporting susceptible colistin results. A resistant Phoenix colistin result does not require alternate testing. BD is not requesting that customers discard, return or discontinue use of the product.
BD is also providing guidance for EpiCenter and BD Phoenix 100 &M50 instrument customers where rules can be created in the software to identify resistant isolates.
This action has been closed out on 17/10/2018 |
| Contact Information |
02 8875 7000 - Customer Service Centre |