| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00141-1 |
| Product Name/Description |
BK Virus R-gene kit when used on SmartCycler 2.0 platform. An in vitro diagnostic medical device (IVD).
(used for measuring the viral load of BK virus in whole blood, plasma and urine samples)
Catalogue Number: 69-013B
ARTG Number: 211361 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Following a customer complaint and an internal investigation, bioMérieux has confirmed that when testing weak viral load samples, in conjunction with BK Virus R-gene kit on SmartCycler 2.0 platform, negative results may be obtained instead of positive as expected. The investigation confirmed that the issue has been observed only with SmartCycler 2.0 and the issue only concerns low viral load samples (viral load equal or below the Sensitivity Control). The issue is detected by the Sensitivity Control (SC) that is the equivalent of a weak positive sample, which will be systematically negative instead of positive in most of the cases. When no Sensitivity Control is systematically run, there is a potential risk to obtain a false negative result. Based on the investigation data, the performances claimed in the IFU regarding the use of SmartCycler 2.0 in conjunction with BK Virus R-gene kit could not be warranted. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
bioMérieux is advising customers to stop using the BK Virus R-gene kit ref. 69-013B on Smart Cycler 2.0. It is recommended that any concern customers have regarding previously reported results is discussed with the Laboratory Medical Director to determine the appropriate course of action.
This action has been closed out on 15/01/2019 |
| Contact Information |
1800 333 421 - bioMérieux Help Desk Department |