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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00380-1
Product Name/Description	Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. An in vitro diagnostic medical device (IVD) Remel PathoDx Strep Grouping Kit 60 Test (R62025) Lot 1470133 Remel PathoDx Strep B Group Latex Lot 1437729 ARTG number: 235676
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/05/2015
Responsible Entity	Thermo Fisher Scientific Australia & New Zealand
Reason/Issue	Investigations by the manufacturer Remel Europe, part of Thermo Fisher Scientific, have confirmed that this batch of Group B reagent may produce weak or slow reactions. Continued use of this batch may result in a failure to identify beta-haemolytic streptococci group B isolates potentially leading to a delay in result reporting and/or a delay to delivering appropriate therapy.
Recall Action	Recall
Recall Action Instructions	Laboratories are requested to cease using and destroy the kits containing the affected reagent. This action has been closed-out on 08/08/2016.
Contact Information	08 8238 9044 - Thermo Fisher Scientific