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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