The Health Canada issued a Type I medical device recall concerning the Process Systems Manager (PSM) Software version 2.02.02c [Model No.: 4944607001] manufactured by Roche Diagnostics Ltd.
According to Health Canada, this recall is about issue with the PSM Software Version 2.02.02c and higher that leads to an unintended change of patient demographics in the PSM Database which could affect the interpretation of results within the PSM Environment.
For details, please refer to the Health Canada website:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php