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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 Biomerieux Australia Pty Ltd
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