| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00069-1 |
| Product Name/Description |
therascreen PyroMark Gold Q24 Reagents and Pyro Buffers. An in vitro diagnostic medical device (IVD)
PyroMark Gold Q24 Reagents
Material Number: 1055272
Lot Numbers: 157010641, 157025615, 157027017, 157030977
therascreen Pyro Buffers and Reagent
Material Number: 1063948
Lot Numbers: 157013230, 157013013, 157027507, 157028499, 157028495, 157030047, 157035803, 157033230
ARTG Number: 226453 (Qiagen Pty Ltd - Acquired genetic alteration IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Qiagen have identified an increased number of cases with altered ratios in the Pyrogram peak patterns for therascreen Pyrosequencing assays. Use of the affected lots is associated with an elevated invalidity and re-testing rate.
In addition, use of the affected lots also creates an elevated risk of A59T false positive results for the Pyrosequencing analysis of NRAS codon 59 with the therascreen RAS Extension Pyro Kit (REF 971590).
In Pyrosequencing runs performed with the affected material, the ratio of the peak height for dATP peaks in Pyrograms is artificially increased while in parallel the peak height for dGTP may be decreased. This may result in an altered ratio of peak heights and consequently leads to an incorrect determination of allele mutation frequencies. |
| Recall Action |
Recall |
| Recall Action Instructions |
Qiagen is advising users to discontinue use of the affected lots and contact Qiagen for replacement lots.
Please ensure the corresponding assay Plug-in reports for automated result interpretation are used.
If users have used the affected lots, it is strongly recommend a review of the corresponding results.
This action has been closed out on the 16/10/2018. |
| Contact Information |
1800 243 800 - Customer Support Centre |