Medical Device Safety Alert: BioMerieux Etest COLISTIN CO256 WW
Medical device manufacturer, BioMerieux, has issued a field safety notice concerning its Etest COLISTIN CO256 WW. The affected product reference numbers are 537300 and 537308.
Based on scientific publications (including EUCAST warning letter on their website) on colistin gradient and disk diffusion tests, the manufacturer was alerted about a potential underestimation of the minimum inhibitory concentrations (MIC) values for Enterobacteriaceae and Acinetobacter, the manufacturer initiated a complaint investigation to confirm product performance and determine root cause. While the internal and external investigations are still ongoing, to date and based on data available, the following have been identified:
- The Etest COLISTIN CO256 performance are depending on the Mueller Hinton agar plate used as described in the Supplement Insert (Ref.16266, version A)- CIS012.
- For the Enterobacteriaceae strains, the first results of the manufacturer’s investigation state that the performance of Etest COLISTIN CO256 are conformed if used in conjunction with the MHE agar (from the manufacturer) with a good concordance rate compared to Broth-Micro Dilution (BMD) method.
- There is a potential of false susceptible results on Etest COLISTIN CO256 WW (Ref. 537300-537308) with some Mueller Hinton agar (except with the MHE agar from the manufacturer for the Enterobacteriaceae strains).
- These data need to be confirmed by the investigations ongoing.
The manufacturer requests users to take the following actions:
- For Enterobacteriaceae strains, users can continue to use the affected lots of Etest COLISTIN CO256 (Ref. 537300- 537308) for diagnostic purposes, only if it is used with MH-E (Mueller Hinton-E agar from the manufacturer’s Ref. 413822-413823-413824-413825) agar. If not, or if users test other strains than Enterobacteriaceae strains, the manufacturer recommends users to restrict its use to epidemiological surveys.
- Among tests previously performed, identify any possible false susceptible results, analyze the related risks and determine appropriate actions if relevant.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 2 August 2016