| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00224-1 |
| Product Name/Description |
Magnetic Silica MagSIL. An in vitro diagnostic medical device (IVD).
(used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)
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 |
27/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
In July 2016 customers were informed about a decrease of extraction performances for some specific downstream applications with 7 batches of MagSIL, which can lead to a risk of false negative, invalid or under-quantification results (TGA Ref.: RC-2016-RN-00949-1). Following this action, bioMérieux put in place several additional quality controls (QC) at the release of batches. The released batches performances have been monitored in real-time for stability. As a result, in Jan 2017 customers were informed that the issue may affect a further 8 MagSIL batches (TGA Ref.: RC-2016-RN-01551-1).The corrective actions provided for the batches under RC-2016-RN-01551-1 remain appropriate. For the 7 batches included in the July 2017 action, a drift of the performance results was observed after a few months of release with the bioMérieux BK-Virus R-gene test. Since one bioMérieux assay is impacted, the usability of these batches with all bioMérieux applications cannot be assured. |
| Recall Action |
Recall |
| Recall Action Instructions |
bioMérieux is advising customers to quarantine the remaining kit from lots Z017BB1MS, Z017BF1MS, Z017BA1MS, Z017CC1MS, Z017CG1MS, Z017DC1MS & Z017DD1MS. bioMérieux will arrange for the return of these kits and also credit/replacement. Any concerns regarding previously reported results should be discussed with the Laboratory Director to determine the appropriate course of action.
This action has been closed out on 26/02/2019 |
| Contact Information |
1800 333 421 - bioMérieux Australia Helpdesk |