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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00388-1
Product Name/Description	CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD) List number: 09H46-02 Lot numbers: 6853, 6901 Expiry date: 31 July 2017 Lot number: 6953 Expiry date: 30 Sep 2017 Lot Numbers: 6991 Expiry date: 30 Nov 2017 Lot Numbers: 7024, 7027 Expiry date: 31 Dec 2017 Lot Number: 7044 Expiry date: 31 Jan 2018 Lot Number: 7082 Expiry date: 28 Feb 2018 Lot Number: 7110 Expiry date: 31 Mar 2018 Lot Number: 7119 Expiry date:30 Apr 2018 ARTG number: 225068
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/04/2016
Responsible Entity	Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue	Abbott has identified occurrences where the CELL-DYN Emerald analyser generates Quality Control (QC) Out Of Range Low for parameters RBC and PLT. Abbott is continuing to investigate but immediate actions by the laboratory are necessary. Abbott has no evidence that there is impact to generated patient results. There is a potential for delay in results due to QC out of range.
Recall Action	Recall
Recall Action Instructions	Abbott is advising users to switch to an alternative lot of Cleaner reagent if available, and destroy any remaining inventory of the affected lots. If users are not experiencing the error and do not have an alternative lot to use, please order a replacement and continue to use the reagent provided internal QC results remain in specification. Users are advised to contact customer support if they are experiencing the error and do not have an alternative lot available. This action has been closed-out on 26/05/2017.
Contact Information	1800 816 696 - Abbott Customer Support