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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00579-1
Product Name/Description Parechovirus r-gene. An in vitro diagnostic medical device (IVD)

Catalogue Number: 71-020

Serial Number: 1002978600

Supplied as Research Use Only

ARTG Number: 211361
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 29/06/2015
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue An internal investigation identified a shift of the Ct values of lnternal Control (IC1 W0, Internal Control with water) inside and outside the limit of specifications.

The investigations performed by R&D with ref. 71-020 lot 1002978600 showed that Ct values results on the extraction control (IC1W0) with Ct value close to the specification of validity (32 Ct) or just above this specification. The Ct shift values may be observed on a positive sample without impacting the limit of detection.
Recall Action Recall for Product Correction
Recall Action Instructions Biomerieux is requesting their customers to discontinue using and discard any remaining inventory of the Parechovirus r-gene ref. 71-020 (WW) lot 1002978600. This action has been closed-out on 17/08/2016.
Contact Information 1800 333 421 - Customer assistance