| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00783-1 |
| Product Name/Description |
Vancomycin Assay (performed on cobas C and Modular Analytics P-Module)
Online TDM Vancomycin
Material Number: 04491050190
Instrument affected: cobas c 501/502 module
Hitachi Vancomycin
Material Number: 04642481190
Instrument affected: MODULAR ANALYTICS P-MODULE
ARTG Number: 174910 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Previously, Roche had received complaints about high recovery of the Vancomycin assay in the context of external survey samples. To correct this, a LC-MS/MS reference method for the quantification of Vancomycin was developed and released in 2014. As a result of this, updated instrument factors were required to correct possible high recovery and to align the various Roche analysers.
For the COBAS INTEGRA system a slight adaptation of the reagent components is required instead of an updated instrument factor. Since the COBAS INTEGRA reagent is not yet adapted, results generated with this reagent are still higher by up to 20% in comparison to the cobas c modules or the Modular Analytics P-Module. The method comparison in the IFU may lead to the assumption that both methods are comparable which may affect the interpretation of Vancomycin test results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Incorrect method comparison will be deleted from the IFUs. Corrected IFU will be provided to all users. In the interim, Roche is advising users to disregard the incorrect method comparison in the Instructions for Use (IFU).
Action was closed out on 20/08/2018 |
| Contact Information |
02 9860 2313 - Roche Diagnostics Australia |