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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00418-1
Product Name/Description	NucliSENS Lysis Buffer. An in vitro diagnostic medical device (IVD) Reference Number: 200292 Lot Number: 16092902 Expiry: 28 Aug 2018 ARTG Number: 240760
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/04/2017
Responsible Entity	Biomerieux Australia Pty Ltd
Reason/Issue	Following a customer complaint about coloured eluates, bioMérieux's investigation confirmed an issue with a single lot of NucliSENS Lysis Buffer. The eluate becomes coloured because of the presence of the heme group from the haemoglobin present in whole blood samples including Dry Blood Spots. The root cause of the coloration is linked to the pH that, for the affected lot, has been observed to be 6.9 instead of 7.1 +/-0.1 as per product specification. The presence of haemoglobin causes the inhibition of the PCR. The result in most of the cases is uninterpretable test results as the Internal Control (IC) would also be inhibited, invalidating the test. In this case, there is a potential risk of delayed results. Considering that the Buffer is used in various protocols and downstream applications, and the worst case scenario in which the IC would not be inhibited, or not used although it is part of good laboratory practices, the tests run could potentially result in false negative results.
Recall Action	Recall
Recall Action Instructions	bioMérieux is advising users to stop using the affected lot of NucliSENs Lysis Buffer and to either quarantine or discard any stock of this lot. BioMerieux will arrange for pick up and credit, as required. Any concerns regarding previously reported results should be discussed with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed out on 13/11/2018
Contact Information	1800 333 421 - bioMérieux Australia