Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Roche Diagnostics GmbH Creatine Kinase (CK) [Model or Catalog Number: 07190794190; Lot or Serial Number: 755471] [HKMD No.: 220074].
According to Health Canada, the manufacturer received complaints from US customers for Creatine Kinase (CK) lot 755471 (expired June-2024) on cobas c 311/501/502 and INTEGRA 400 plus about abnormal calibration signals, flagged calibrations (Sens.E) and control recovery issues. Subsequent investigation identified a positive bias at the lower measuring range and a negative bias at the higher measuring range. The issue affects a small number of cassettes of the mentioned lot.
For further information, please visit: https://recalls-rappels.canada.ca/en/alert-recall/creatine-kinase-ck
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 Sep 2024