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 Beckman Coulter Inc Coulter DxH Diluent [Model or Catalogue Number: 628017] [HKMD No.: 200395].
According to the Health Canada, the manufacturer has confirmed that specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications. Quality control results may fail to flag for the affected parameters. Not all diluent containers within the affected lots exhibited the issue.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/coulter-dxh-diluent
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Jun 2023