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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01531-1
Product Name/Description	CELL-DYN Emerald 22 Analyser with software version v3.0.0. An in vitro diagnostic medical device (IVD) List Number: 09H59-01 Serial Number: below 000700 ARTG Number: 199356
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	19/12/2017
Responsible Entity	Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue	Abbott Hematology has identified the following issue with the CELL-DYN Emerald 22 Analyser Application Software v3.0.0 when the IUO (Information Use Only) reporting option is disabled. For the printout of the Levey-Jennings (L-J) graphs, the WBC Subpopulation differential labels do not match the L-J graphs. The labels are displayed in the following order: LYM%, MON%, NEU%, EOS% and BAS%, instead of NEU%, LYM%, MON%, EOS%, and BAS%. The graphs themselves are in the order of NEU%, LYM%, MON%, EOS%, and BAS%. All printed QC raw data results are correct
Recall Action	Recall for Product Correction
Recall Action Instructions	Abbott is advising users to stop using the printouts of the Levey-Jennings (L-J) graphs and use the QC results or the on-screen display. A software upgrade will be performed as a permanent correction. This action has been closed out on the 21/11/2018.
Contact Information	1800 816 696 - Abbott Australia