| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00806-1 |
| Product Name/Description |
BK Virus R-gene Real-time Detection and Quantification Kit. An in vitro diagnostic medical device (IVD)
Reference Number: 69-013B
Pack Size: 90 tests
IFU Version: 21258D
Lot Numbers: 1004754140 and 1004764070
Expiration Date: 4 Feb 2018
IFU Version: 21258E (new version)
Lot Numbers: 1004965280
Expiration Date: 22 Nov 2018
ARTG Number: 211361 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
bioMérieux has observed significant differences between the Fit Point and 2nd derivative analysis methods on LightCycler amplification platforms for low positive whole blood samples.
Investigation showed that the significant differences (>0,5 log10 cp/mL) have been obtained for BK virus low viral loads (inferior to around 25 000 cp/mL - corresponding to around 4.40 log10 cp/mL - determined by Fit Point) on whole blood samples with the BK Virus R-gene assay. These differences between the two methods are due to the shape of the curves for low positive whole blood samples. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are requested to take the following actions at this time:
? Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product.
? Stop using the 2nd derivative method for whole blood samples on LightCycler 1.0, 2.0 and 480 until the improved BK Virus R-gene kit was released. Use the Fit Point method with these LightCyclers.
? Contact your local customer service if you observe the issue.
This action has been closed out on 05/03/2020 |
| Contact Information |
1800 333 421 - bioMerieux Australia |