| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00949-1 |
| Product Name/Description |
NucliSENS easyMAG Magnetic Silica MagSIL (used with the NucliSENS easyMag nucleic acid extraction system for the automated extraction of total nucleic acids (RNA/DNA) from biological samples). An in vitro diagnostic medical device (IVD)
Catalogue Number: 280133
Lot Numbers:
Z017BB1MS, Z017BF1MS, Z017BA1MS
Expiry Date: 28/02/2017
Z017CC1MS, Z017CG1MS
Expiry Date: 28/03/2017
Z017DC1MS, Z017DD1MS
Expiry Date: 28/04/2017
ARTG Number: 240760 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Following customer complaints about amplification performance issues with home brew PCR and RT- PCR assays, bioMérieux investigation has confirmed an issue with specific batches of Magnetic Silica (ref: 280133). The investigation concluded that downstream applications were impacted when the extraction volume was higher than 400µL and for double stranded nucleic acids target. Double stranded nucleic acid applications with small (< 40Kbp) and medium genome sizes (< to 1200 Kbp) i.e., DNA viruses are more impacted than higher human genomic DNA and bacterial applications (> to 1200Kbp).
This may result in false negative, invalid or under-quantification of results. If invalid results are obtained, it could lead to a delayed result until a new run or a new extraction is performed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
bioMérieux is advising users to ensure controls with the same nature/structure as the target and/or external controls are used to detect the issue. Users are advised to reduce the sample input volume to 200µL, until the silica problems is resolved.
Downstream ARGENE and NucliSENS easyQ HIV 1 V2.0 applications performed according to the IFU are not affected.
It is recommended that the continued use with blood transfusion testing with confirmed by the Laboratory Director, and to discuss any concerns regarding previously reported results with the Laboratory Director.
This action has been closed out on 19/10/2018 |
| Contact Information |
1800 333 421 - bioMérieux Australia |