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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01441-1
Product Name/Description	Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. An in vitro diagnostic medical device (IVD) Product code: R30164201 Lot Numbers: 1465529, 2118879, 2173683, 2161363, 2149414, 2135578, 1738564, 1957305, 1947930, 1847285 ARTG Number: 236824
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/11/2017
Responsible Entity	Thermo Fisher Scientific Australia & New Zealand
Reason/Issue	Thermo Fisher Scientific, has confirmed that Shigella sonnei (Phases 1& 2) Agglutinating Serum may fail to agglutinate within the specified minimum reaction time when tested with Shigella sonnei phase 2 bacteria. Continued use of these lots may result in a failure to correctly identify isolates as Shigella sonnei phase 2. The products continue to correctly identify Shigella sonnei phase 1 bacteria.
Recall Action	Recall
Recall Action Instructions	Thermo fisher is advising users to inspect stock and remove any remaining units of the affected batches from use. A review of previously generated patient results is at the discretion of the Laboratory Manager. This action has been closed out on 19/11/2018
Contact Information	08 8238 9044 - Thermo Fisher Scientific